JP2017209427A - Percutaneous administration device and medicament administration instrument - Google Patents

Percutaneous administration device and medicament administration instrument Download PDF

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JP2017209427A
JP2017209427A JP2016106541A JP2016106541A JP2017209427A JP 2017209427 A JP2017209427 A JP 2017209427A JP 2016106541 A JP2016106541 A JP 2016106541A JP 2016106541 A JP2016106541 A JP 2016106541A JP 2017209427 A JP2017209427 A JP 2017209427A
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elastic member
administration device
protrusion
skin
transdermal administration
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JP6884992B2 (en
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亮一 旭井
Ryoichi Asai
亮一 旭井
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Toppan Inc
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Toppan Printing Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide a percutaneous administration device and medicament administration instrument capable of smoothly administering a medicament.SOLUTION: A percutaneous administration device 10 includes: a cylindrical base body 21 for passing a medicament, the base body 21 having a support surface 21S at one of two cylindrical ends of the base body 21; a projection part 22 projecting from the support face 21S, the projection part 22 formed with a through-hole 23 which penetrates through the projection part 22 in an extension direction of the projection part 22 and is communicated with an internal space of the base body 21; and an elastic member 30 located on the support face 21S, the elastic body having tackiness.SELECTED DRAWING: Figure 2

Description

本発明は、薬剤の投与に用いられる経皮投与デバイス、および、経皮投与デバイスを備える薬剤投与器具に関する。   The present invention relates to a transdermal administration device used for administration of a drug and a drug administration device including the transdermal administration device.

経皮投与デバイスは、薬剤をその投与対象に対して皮膚から投与するための投与部を備えている。投与部の一例であるマイクロニードルは、針形状を有する突起部を基体部の表面に有している(例えば、特許文献1参照)。マイクロニードルを用いる投与方法は、突起部を皮膚に刺すことによって皮膚に孔を形成し、この孔から薬剤を皮内に送り込むことで薬剤を投与する。マイクロニードルを用いる投与方法であれば、突起部の長さが微小であるため、注射針を用いて皮下に薬剤を投与する方法と比べて、皮膚に孔が形成されるときの痛みが抑えられる。   The transdermal administration device includes an administration unit for administering a drug from the skin to the administration target. A microneedle, which is an example of an administration unit, has a protrusion having a needle shape on the surface of a base body (see, for example, Patent Document 1). In the administration method using microneedles, a hole is formed in the skin by piercing the skin with a protrusion, and the drug is administered by feeding the drug into the skin through this hole. If the administration method using microneedles, the length of the protrusion is very small, so that pain when pores are formed in the skin can be suppressed compared to the method of administering the drug subcutaneously using an injection needle. .

マイクロニードルを用いる投与方法の1つでは、突起部の延びる方向に基体部と突起部とを貫通する貫通孔が形成されたマイクロニードルが用いられ、貫通孔を通して液状の薬剤が皮内に投与される(例えば、特許文献2参照)。こうしたマイクロニードルは、例えば、注射針のようにシリンジに取り付けられて用いられる。   In one administration method using a microneedle, a microneedle having a through-hole penetrating the base portion and the protrusion in the extending direction of the protrusion is used, and a liquid drug is administered into the skin through the through-hole. (For example, see Patent Document 2). Such a microneedle is used by being attached to a syringe like an injection needle, for example.

特許第4427691号明細書Japanese Patent No. 4276691 特開2005−21677号公報Japanese Patent Laid-Open No. 2005-21677

ところで、薬剤の投与対象における皮膚の表面には、外部からの刺激や外部からの有害物から体内を守る機能であるバリア機能を有した角質層が存在する。投与対象の体内に薬剤を的確に送り込むためには、経皮投与デバイスの使用者は、皮膚の内部の組織よりも硬いこうした角質層を突起部が貫通する程度の力で、マイクロニードルを皮膚に押し付ける必要がある。ところが、こうした押圧力によってマイクロニードルが皮膚に押し付けられていると、皮内の組織が押圧されて詰まった状態となるため、突起部の貫通孔から出た薬剤が組織内に浸透しにくい。
本発明は、薬剤を円滑に投与することのできる経皮投与デバイスおよび薬剤投与器具を提供することを目的とする。
By the way, there is a stratum corneum having a barrier function, which is a function of protecting the body from external stimuli and harmful substances from the outside, on the surface of the skin of a drug administration target. In order to accurately deliver the drug into the body of the administration subject, the user of the transdermal administration device must place the microneedle in the skin with a force that allows the protrusion to penetrate the stratum corneum, which is harder than the tissue inside the skin. It is necessary to press. However, when the microneedle is pressed against the skin by such a pressing force, the tissue in the skin is pressed and becomes clogged, so that the drug that has come out of the through hole of the protruding portion does not easily penetrate into the tissue.
An object of the present invention is to provide a transdermal administration device and a drug administration device capable of smoothly administering a drug.

上記課題を解決する経皮投与デバイスは、薬剤を通す筒状の基体部であって、当該基体部における2つの筒端の一方に支持面を有する前記基体部と、前記支持面から突き出た突起部であって、前記突起部の延びる方向に当該突起部を貫通して前記基体部の内部空間に連通する貫通孔が形成されている前記突起部と、前記支持面に位置し、粘着性を有した弾性体である弾性部材と、を備える。   A transdermal administration device that solves the above-described problem is a cylindrical base portion through which a drug passes, the base portion having a support surface at one of two cylindrical ends of the base portion, and a protrusion protruding from the support surface A protrusion formed in a through hole that extends through the protrusion in the extending direction of the protrusion and communicates with the internal space of the base portion; And an elastic member that is an elastic body.

上記構成によれば、投与対象の皮膚に突起部が刺さる程度に、経皮投与デバイスが皮膚に押し付けられたとき、支持面と皮膚の表面との間で弾性部材が圧縮された状態で弾性部材が皮膚の表面に貼り付く。そして、経皮投与デバイスに加えられている押圧力が弱められると、弾性部材の形状が復元することに伴って、基体部と突起部とは皮膚の表面から離れる方向に動き、経皮投与デバイスによる皮膚に対する押圧が弱められる。このとき、弾性部材が皮膚の表面に貼り付いているため、支持面が皮膚の表面から過剰に離れること、ひいては、突起部が皮膚から抜け出てしまうことが抑えられる。したがって、角質層を貫通するように力を加えて突起部を皮膚に刺しつつも、刺さった突起部が皮膚から抜け出ることを抑えながら皮膚への押圧を弱めて、皮内へ薬剤が浸透しやすくすることが可能であり、この状態で貫通孔を通じて薬剤を投与することによって、薬剤の円滑な投与が可能である。   According to the above configuration, the elastic member is compressed between the support surface and the surface of the skin when the transdermal administration device is pressed against the skin to such an extent that the protrusion is stuck in the skin to be administered. Sticks to the surface of the skin. When the pressing force applied to the transdermal administration device is weakened, the shape of the elastic member is restored, so that the base portion and the protrusion move away from the surface of the skin, and the transdermal administration device The pressure on the skin due to is reduced. At this time, since the elastic member is adhered to the surface of the skin, it is possible to prevent the support surface from being excessively separated from the surface of the skin and, in turn, the protruding portion from slipping out of the skin. Therefore, while applying a force to penetrate the stratum corneum and piercing the skin into the skin, weakening the pressure on the skin while preventing the pierced protrusion from coming out of the skin, it is easy for the drug to penetrate into the skin By administering the drug through the through-hole in this state, it is possible to smoothly administer the drug.

上記構成において、前記支持面と対向する方向から見て、前記弾性部材は、前記突起部の周囲を取り囲んでいてもよい。
上記構成によれば、突起部の周囲を取り囲む位置で、経皮投与デバイスが皮膚に貼り付くため、皮膚に対する突起部の位置の安定性が高められる。
上記構成において、前記経皮投与デバイスは、複数の前記突起部を備え、前記支持面と対向する方向から見て、前記弾性部材は、前記複数の突起部からなる集合を取り囲んでいてもよい。
The said structure WHEREIN: The said elastic member may surround the circumference | surroundings of the said projection part seeing from the direction facing the said support surface.
According to the above configuration, since the transdermal administration device sticks to the skin at a position surrounding the protrusion, the stability of the position of the protrusion with respect to the skin is enhanced.
In the above configuration, the transdermal administration device may include a plurality of protrusions, and the elastic member may surround a set of the plurality of protrusions when viewed from a direction facing the support surface.

上記構成によれば、弾性部材が突起部を1つずつ取り囲む構成と比較して、弾性部材の形状が複雑になることや弾性部材における形状の精度が得られがたくなることが抑えられるため、弾性部材の形成が容易である。
上記構成において、前記経皮投与デバイスは、複数の前記突起部を備え、前記支持面と対向する方向から見て、前記弾性部材は、前記突起部を1つずつ取り囲んでいてもよい。
According to the above configuration, the elastic member can suppress the complexity of the shape of the elastic member and the difficulty in obtaining the accuracy of the shape of the elastic member as compared to the configuration in which the elastic member surrounds the protrusions one by one. The elastic member can be easily formed.
In the above configuration, the transdermal administration device may include a plurality of the protrusions, and the elastic member may surround the protrusions one by one when viewed from a direction facing the support surface.

上記構成によれば、複数の突起部からなる集合を1つの弾性部材が取り囲む形態と比較して、支持面において弾性部材が占有する面積を大きく確保しやすい。したがって、皮膚の表面に貼り付く弾性部材の面積を大きく確保しやすいため、皮膚に対する突起部の位置の安定性が高められる。   According to the above configuration, it is easy to ensure a large area occupied by the elastic member on the support surface, as compared with a form in which one elastic member surrounds a set of a plurality of protrusions. Therefore, since the area of the elastic member attached to the surface of the skin can be easily secured, the stability of the position of the protrusion with respect to the skin is enhanced.

上記構成において、前記経皮投与デバイスは、複数の前記弾性部材を備えてもよい。
上記構成によれば、弾性部材の配置や弾性部材の発揮する機能についての調整の自由度が高められる。
上記構成において、前記複数の弾性部材には、特性の異なる複数の前記弾性部材が含まれ、前記特性は、前記弾性部材の弾性率、前記弾性部材の有する粘着性、および、前記突起部の延びる方向における前記弾性部材の最大の長さの少なくとも1つであってもよい。
In the above configuration, the transdermal administration device may include a plurality of the elastic members.
According to the said structure, the freedom degree of adjustment about the arrangement | positioning of an elastic member and the function which an elastic member exhibits is raised.
In the above configuration, the plurality of elastic members include a plurality of elastic members having different characteristics, and the characteristics include an elastic modulus of the elastic member, an adhesive property of the elastic member, and an extension of the protrusion. It may be at least one of the maximum lengths of the elastic member in the direction.

上記構成によれば、支持面内での位置による押圧力のばらつきや薬剤の投与部位内での皮膚の伸びやすさのばらつき等に応じて、突起部における皮膚に刺さる長さを調整することや、支持面内での位置に応じて経皮投与デバイスが皮膚に貼り付く強さを調整することができる。
上記構成において、前記突起部の延びる方向における前記弾性部材の長さが各々で異なる複数の部位を前記弾性部材が有してもよい。
According to the above configuration, the length of the protrusion in the skin can be adjusted according to the variation in the pressing force depending on the position in the support surface, the variation in the easiness of the skin in the administration site of the drug, etc. The strength with which the transdermal administration device sticks to the skin can be adjusted according to the position within the support surface.
The said structure WHEREIN: The said elastic member may have several site | parts from which the length of the said elastic member differs in the direction where the said protrusion part extends, respectively.

上記構成によれば、弾性部材における各部位で弾性部材の長さが異なるため、支持面内での位置に応じて皮膚に刺さる突起部の長さや皮膚の伸びを調整したり、経皮投与デバイスの皮膚への貼り付き方を調整したりすることができる。   According to the above configuration, since the length of the elastic member is different at each part of the elastic member, the length of the protruding portion that pierces the skin and the elongation of the skin can be adjusted according to the position in the support surface, or the transdermal administration device It is possible to adjust how the skin sticks to the skin.

上記課題を解決する薬剤投与器具は、上記経皮投与デバイスと、薬剤の投与対象に巻きつけられる投与補助具と、を備える薬剤投与器具であって、前記投与補助具は、帯状に延びるバンド部と、前記バンド部に形成された開口部であって、前記経皮投与デバイスの前記支持面を挿入可能な大きさを有する前記開口部、および、前記開口部を塞ぐように開閉可能な蓋部を含む投与位置規定部と、前記バンド部の延びる方向における当該バンド部の両端部を互いに固定可能に構成された固定部と、を備える。   A drug administration device that solves the above-described problem is a drug administration device that includes the transdermal administration device and an administration aid wrapped around an administration target of the drug, the administration aid having a band portion that extends in a band shape. An opening formed in the band portion, the opening having a size that allows the support surface of the transdermal administration device to be inserted, and a lid that can be opened and closed so as to close the opening. And a fixing portion configured such that both ends of the band portion in the extending direction of the band portion can be fixed to each other.

上記構成によれば、投与補助具を薬剤の投与対象に巻き付けた後、開口部に経皮投与デバイスを挿入して突起部を開口部内の皮膚に刺し、薬剤を投与することによって、皮膚に対する経皮投与デバイスの位置決め、すなわち、薬剤を投与する位置の位置決めを容易に行うことができる。また、薬剤の投与中における皮膚に対する経皮投与デバイスの位置の安定性も高められる。さらに、薬剤の投与後に蓋部によって開口部を塞ぐことにより、投与された薬剤の体内への浸透が補助される。したがって、上記経皮投与デバイスを用いた円滑な薬剤の投与を容易に進めることができる。   According to the above configuration, after the administration aid is wrapped around the administration target of the drug, the transdermal administration device is inserted into the opening, the protrusion is pierced into the skin in the opening, and the drug is administered, whereby It is possible to easily position the skin administration device, that is, the position to administer the drug. In addition, the stability of the position of the transdermal administration device with respect to the skin during the administration of the drug is enhanced. Furthermore, the penetration of the administered drug into the body is assisted by closing the opening with the lid after the administration of the drug. Therefore, smooth drug administration using the transdermal administration device can be facilitated.

本発明によれば、経皮投与デバイスによって薬剤を円滑に投与することができる。   ADVANTAGE OF THE INVENTION According to this invention, a chemical | medical agent can be smoothly administered with a transdermal administration device.

経皮投与デバイスの一実施形態について、経皮投与デバイスの全体構成を示す分解斜視図。The exploded perspective view which shows the whole structure of a transdermal administration device about one Embodiment of a transdermal administration device. 一実施形態の経皮投与デバイスにおける断面構造を示す断面図。Sectional drawing which shows the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造を示す平面図。The top view which shows the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスが皮膚に押し付けられた状態を模式的に示す図。The figure which shows typically the state by which the transdermal administration device of one Embodiment was pressed on skin. 一実施形態の経皮投与デバイスが皮膚に押し付けられた後、押圧力が弱められた状態を模式的に示す図。The figure which shows typically the state by which the pressing force was weakened after the transdermal administration device of one Embodiment was pressed on skin. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける平面構造の他の例を示す平面図。The top view which shows the other example of the planar structure in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の経皮投与デバイスにおける断面構造の他の例を示す断面図。Sectional drawing which shows the other example of the cross-section in the transdermal administration device of one Embodiment. 一実施形態の投与補助具の平面構造を示す平面図。The top view which shows the planar structure of the administration assistance tool of one Embodiment. 一実施形態の投与補助具が薬剤の投与対象の肢体に装着された状態を模式的に示す図。The figure which shows typically the state with which the administration assistance tool of one Embodiment was mounted | worn with the limbs of the administration object of a chemical | medical agent. 一実施形態の投与補助具が薬剤の投与対象の肢体に装着された状態を模式的に示す図。The figure which shows typically the state with which the administration assistance tool of one Embodiment was mounted | worn with the limbs of the administration object of a chemical | medical agent. 一実施形態の薬剤投与器具の構成をシリンジとともに示す図。The figure which shows the structure of the chemical | medical agent administration instrument of one Embodiment with a syringe. 一実施形態の経皮投与デバイスをカバー部材が貼り付けられた状態で示す斜視図。The perspective view which shows the transdermal administration device of one Embodiment in the state by which the cover member was affixed. 一実施形態の薬剤投与器具を用いて薬剤が投与される手順を示す図であって、投与補助具が薬剤の投与対象に巻き付けられた状態を模式的に示す図。The figure which shows the procedure in which a chemical | medical agent is administered using the chemical | medical agent administration apparatus of one Embodiment, Comprising: The figure which shows the state by which the administration assistance tool was wound around the administration subject of a chemical | medical agent. 一実施形態の薬剤投与器具を用いて薬剤が投与される手順を示す図であって、経皮投与デバイスが皮膚に押し付けられた状態を模式的に示す図。The figure which shows the procedure in which a chemical | medical agent is administered using the chemical | medical agent administration instrument of one Embodiment, Comprising: The figure which shows the state by which the transdermal administration device was pressed on skin. 一実施形態の薬剤投与器具を用いて薬剤が投与される手順を示す図であって、経皮投与デバイスが皮膚に押し付けられた後、押圧力が弱められた状態を模式的に示す図。The figure which shows the procedure in which a chemical | medical agent is administered using the chemical | medical agent administration instrument of one Embodiment, Comprising: The figure which shows the state by which the pressing force was weakened after the transdermal administration device was pressed on skin. 一実施形態の薬剤投与器具を用いて薬剤が投与される手順を示す図であって、薬剤の投与後に薬剤の投与部位が保護された状態を模式的に示す図。The figure which shows the procedure in which a chemical | medical agent is administered using the chemical | medical agent administration apparatus of one Embodiment, Comprising: The figure which shows typically the state by which the administration site | part of the chemical | medical agent was protected after administration of a chemical | medical agent.

図1〜図52を参照して、経皮投与デバイスおよび薬剤投与器具の一実施形態について説明する。
[経皮投与デバイスの構成]
図1〜図3を参照して、経皮投与デバイスの構成について説明する。
図1が示すように、経皮投与デバイス10は、投与部の一例であるマイクロニードル20と、弾性部材30とを備えている。
1 to 52, an embodiment of a transdermal administration device and a drug administration device will be described.
[Configuration of transdermal administration device]
The configuration of the transdermal administration device will be described with reference to FIGS.
As shown in FIG. 1, the transdermal administration device 10 includes a microneedle 20 that is an example of an administration unit, and an elastic member 30.

マイクロニードル20は、筒状の基体部21と、基体部21から突き出た突起部22とを備えている。弾性部材30は、環状を有し、突起部22を囲む位置に配置されている。   The microneedle 20 includes a cylindrical base portion 21 and a protruding portion 22 protruding from the base portion 21. The elastic member 30 has an annular shape and is disposed at a position surrounding the protrusion 22.

図2が示すように、基体部21は、基体部21の有する2つの筒端の一方に、端面として支持面21Sを有している。基体部21の有する2つの筒端のうち、支持面21Sと反対側の筒端は開口されている。   As shown in FIG. 2, the base portion 21 has a support surface 21 </ b> S as an end surface at one of the two cylindrical ends of the base portion 21. Of the two cylinder ends of the base portion 21, the cylinder end opposite to the support surface 21S is opened.

基体部21の外形は特に限定されず、基体部21は、円筒形状を有していてもよいし、角筒形状を有していてもよい。そして、支持面21Sは、基体部21の形状に応じた形状を有していればよい。また、基体部21は、2つの筒端の間に、外径が徐々に変化する部分や、外径が段階的に変化する部分を有していてもよい。図1〜図3に示す例では、基体部21は円筒形状を有し、支持面21Sは円形状を有している。   The outer shape of the base portion 21 is not particularly limited, and the base portion 21 may have a cylindrical shape or a rectangular tube shape. And the support surface 21S should just have the shape according to the shape of the base | substrate part 21. FIG. Moreover, the base | substrate part 21 may have a part from which an outer diameter changes gradually between two cylinder ends, and a part from which an outer diameter changes in steps. In the example shown in FIGS. 1 to 3, the base portion 21 has a cylindrical shape, and the support surface 21 </ b> S has a circular shape.

突起部22は、支持面21Sから突き出ており、支持面21Sは、突起部22の基端を支持している。突起部22は、支持面21Sに対して、基体部21が筒状に延びる方向とは反対方向に延びている。突起部22の形状は、皮膚を刺すことが可能な形状であれば特に限定されず、突起部22は、円錐形状や角錐形状を有していてもよいし、円柱形状や多角柱形状を有していてもよい。図1〜図3に示す例では、突起部22は略円錐形状を有している。また、マイクロニードル20の備える突起部22の数は1つであってもよいし、複数であってもよい。図1〜図3に示す例では、マイクロニードル20は複数の突起部22を備えている。   The protrusion 22 protrudes from the support surface 21 </ b> S, and the support surface 21 </ b> S supports the base end of the protrusion 22. The protrusion 22 extends in a direction opposite to the direction in which the base portion 21 extends in a cylindrical shape with respect to the support surface 21S. The shape of the protrusion 22 is not particularly limited as long as it can pierce the skin. The protrusion 22 may have a conical shape or a pyramid shape, or may have a cylindrical shape or a polygonal prism shape. You may do it. In the example shown in FIGS. 1 to 3, the protrusion 22 has a substantially conical shape. Further, the number of the protrusions 22 included in the microneedle 20 may be one or plural. In the example shown in FIGS. 1 to 3, the microneedle 20 includes a plurality of protrusions 22.

突起部22には、突起部22の延びる方向に突起部22を貫通する貫通孔23が形成されている。支持面21Sと対向する方向から見て、貫通孔23は、突起部22の中央に位置してもよいし、中央とは異なる位置に配置されていてもよい。貫通孔23は、基体部21における支持面21Sを有する側壁を貫通して基体部21の内部に達している。すなわち、貫通孔23は、基体部21の内部空間と連通しており、基体部21の内側面と貫通孔23を区画する面とは、薬剤の流路を形成している。薬剤の投与に際して、基体部21の内部空間に供給された薬剤は、貫通孔23を通り、突起部22の先端部分の開口から経皮投与デバイス10の外部へ出る。
弾性部材30は、粘着性を有する弾性体であり、支持面21Sにて突起部22の周囲を取り囲む位置に配置されている。
A through hole 23 is formed in the protrusion 22 so as to penetrate the protrusion 22 in the direction in which the protrusion 22 extends. When viewed from the direction facing the support surface 21S, the through hole 23 may be located at the center of the protrusion 22 or may be disposed at a position different from the center. The through hole 23 penetrates the side wall having the support surface 21 </ b> S in the base portion 21 and reaches the inside of the base portion 21. That is, the through hole 23 communicates with the internal space of the base portion 21, and the inner surface of the base portion 21 and the surface that defines the through hole 23 form a drug flow path. During the administration of the drug, the drug supplied to the internal space of the base portion 21 passes through the through hole 23 and exits from the opening at the tip portion of the protrusion 22 to the outside of the transdermal administration device 10.
The elastic member 30 is an elastic body having adhesiveness, and is disposed at a position surrounding the periphery of the protruding portion 22 by the support surface 21S.

突起部22の最大長Hは、突起部22の延びる方向、すなわち、支持面21Sと直交する方向における突起部22の最大の長さであって、すなわち、支持面21Sから突起部22の先端までの長さである。弾性部材30の最大長Tは、突起部22の延びる方向における弾性部材30の最大の長さであって、すなわち、支持面21Sから弾性部材30の先端までの長さである。図1〜図3に示す例では、突起部22の延びる方向における弾性部材30の長さは、弾性部材30のなかで一定である。突起部22の最大長Hは、例えば、100μm以上3000μm以下の範囲内の長さであり、弾性部材30の最大長Tは、例えば、50μm以上2500μm以下の範囲内の長さである。   The maximum length H of the protrusion 22 is the maximum length of the protrusion 22 in the direction in which the protrusion 22 extends, that is, the direction orthogonal to the support surface 21S, that is, from the support surface 21S to the tip of the protrusion 22. Is the length of The maximum length T of the elastic member 30 is the maximum length of the elastic member 30 in the extending direction of the protrusion 22, that is, the length from the support surface 21 </ b> S to the tip of the elastic member 30. In the example shown in FIGS. 1 to 3, the length of the elastic member 30 in the extending direction of the protrusion 22 is constant in the elastic member 30. The maximum length H of the protrusion 22 is, for example, a length in the range of 100 μm or more and 3000 μm or less, and the maximum length T of the elastic member 30 is, for example, a length in the range of 50 μm or more and 2500 μm or less.

突起部22の最大長Hは、弾性部材30の最大長Tよりも大きいことが好ましい。すなわち、支持面21Sに沿った方向から見て、突起部22の先端は、弾性部材30よりも飛び出ていることが好ましい。こうした構成であれば、薬剤の投与に際して、弾性部材30よりも先に突起部22の先端が投与対象の皮膚に接触するため、突起部22が皮膚に刺さりやすい。   The maximum length H of the protrusion 22 is preferably larger than the maximum length T of the elastic member 30. That is, it is preferable that the tip of the protrusion 22 protrudes from the elastic member 30 when viewed from the direction along the support surface 21 </ b> S. With such a configuration, when the drug is administered, since the tip of the protrusion 22 comes into contact with the skin to be administered before the elastic member 30, the protrusion 22 is likely to be stuck into the skin.

突起部22の最大長Hは、皮膚の断面方向における薬剤の投与位置、すなわち、皮膚に薬剤が投与されているときに突起部22の先端が位置すべき深さや、弾性部材30の最大長Tおよび弾性率に応じて設定される。また、弾性部材30の最大長Tは、弾性部材30の弾性率や、突起部22の最大長H、皮膚の断面方向における薬剤の投与位置に応じて設定される。   The maximum length H of the protrusion 22 is the drug administration position in the cross-sectional direction of the skin, that is, the depth at which the tip of the protrusion 22 should be positioned when the drug is being administered to the skin, or the maximum length T of the elastic member 30. And is set according to the elastic modulus. The maximum length T of the elastic member 30 is set according to the elastic modulus of the elastic member 30, the maximum length H of the protrusion 22, and the administration position of the drug in the skin cross-sectional direction.

突起部22の最大幅Dは、基体部21の支持面21Sに沿った方向における突起部22の長さの最大値である。例えば、突起部22が円錐形状を有するとき、突起部22の底部によって区画された円の直径が、突起部22の最大幅Dである。突起部22の最大幅Dは、例えば、100μm以上1000μm以下の範囲内の長さであり、突起部22の最大幅Dに対する最大長Hの比であるアスペクト比A(A=H/D)は、1以上10以下であることが好ましい。   The maximum width D of the protrusion 22 is the maximum value of the length of the protrusion 22 in the direction along the support surface 21 </ b> S of the base body 21. For example, when the protrusion 22 has a conical shape, the diameter of a circle defined by the bottom of the protrusion 22 is the maximum width D of the protrusion 22. The maximum width D of the protrusion 22 is, for example, a length in the range of 100 μm or more and 1000 μm or less, and the aspect ratio A (A = H / D) that is the ratio of the maximum length H to the maximum width D of the protrusion 22 is 1 or more and 10 or less are preferable.

図3は、支持面21Sと対向する方向から経皮投与デバイス10を見た図であって、弾性部材30を、ドットを付して示している。図3が示すように、弾性部材30は、支持面21Sの外縁に沿って配置され、複数の突起部22からなる集合を取り囲んでいる。   FIG. 3 is a view of the transdermal administration device 10 viewed from the direction facing the support surface 21S, and shows the elastic member 30 with dots. As shown in FIG. 3, the elastic member 30 is disposed along the outer edge of the support surface 21 </ b> S and surrounds a set of the plurality of protrusions 22.

[経皮投与デバイスを用いた薬剤の投与]
図4および図5を参照して、経皮投与デバイス10を用いた薬剤の投与の手順について説明する。
図4が示すように、突起部22の先端が皮膚Skの表面に向けられて、経皮投与デバイス10が皮膚Skに押し付けられる。この際、経皮投与デバイス10には、突起部22が皮膚の角質層を貫通する程度の力が加えられる。これによって、突起部22は角質層を貫通して皮膚Skに刺さり、弾性部材30は押圧力を受けて突起部22の延びる方向に圧縮される。このとき、弾性部材30は支持面21Sと皮膚Skの表面との間に挟まれ、弾性部材30は皮膚Skの表面に接触している。
[Drug administration using transdermal device]
With reference to FIG. 4 and FIG. 5, the procedure of the administration of the medicine using the transdermal administration device 10 will be described.
As shown in FIG. 4, the tip of the protrusion 22 is directed to the surface of the skin Sk, and the transdermal administration device 10 is pressed against the skin Sk. At this time, the transdermal administration device 10 is applied with such a force that the protrusion 22 penetrates the stratum corneum of the skin. As a result, the protrusion 22 penetrates the stratum corneum and pierces the skin Sk, and the elastic member 30 receives a pressing force and is compressed in the extending direction of the protrusion 22. At this time, the elastic member 30 is sandwiched between the support surface 21S and the surface of the skin Sk, and the elastic member 30 is in contact with the surface of the skin Sk.

図5が示すように、突起部22が皮膚Skに刺さると、経皮投与デバイス10に加えられている押圧が解除される。これにより、弾性部材30が復元し、弾性部材30の大きさは、押圧を受ける前の通常状態まで戻り、弾性部材30の厚みの増加に伴って、基体部21は皮膚Skの表面から離れる方向に動く。それとともに、突起部22の位置も皮膚Skの表面に向けて戻り、突起部22のなかで皮膚Skに刺さっている部分の長さは短くなる。このとき、弾性部材30はその粘着力によって皮膚Skの表面に貼り付いているため、突起部22が皮膚Skから抜け出たり突起部22が皮膚Skの中で傾いたりすることが抑えられる。   As shown in FIG. 5, when the protrusion 22 is pierced into the skin Sk, the pressure applied to the transdermal administration device 10 is released. Thereby, the elastic member 30 is restored, and the size of the elastic member 30 returns to the normal state before receiving the pressure, and the base portion 21 moves away from the surface of the skin Sk as the thickness of the elastic member 30 increases. It moves to. At the same time, the position of the protruding portion 22 also returns toward the surface of the skin Sk, and the length of the portion of the protruding portion 22 that is stuck in the skin Sk is shortened. At this time, since the elastic member 30 is adhered to the surface of the skin Sk by the adhesive force, the protrusion 22 is prevented from slipping out of the skin Sk or the protrusion 22 being inclined in the skin Sk.

これにより、皮膚Skに対する押圧が解除されるため、皮膚Skの潰れが解消され、その結果、皮内へ薬剤が浸透しやすくなる。このように、押圧が解除された状態で、薬剤が投与される。薬剤は、外部から基体部21の内部空間に供給され、基体部21と貫通孔23を通って突起部22の先端から出て、皮内に拡散される。   Thereby, since the press with respect to skin Sk is cancelled | released, crushing of skin Sk is eliminated, As a result, it becomes easy to osmose | permeate a chemical | medical agent in skin. Thus, the medicine is administered in a state where the pressure is released. The medicine is supplied from the outside to the internal space of the base portion 21, passes through the base portion 21 and the through hole 23, exits from the tip of the protruding portion 22, and is diffused into the skin.

こうした構成においては、突起部22の最大長Hは、突起部22の最大長Hと弾性部材30の最大長Tとの差、換言すれば、突起部22のなかで通常状態での弾性部材30よりも飛び出ている部分の長さが、投与対象の皮膚における表面から、薬剤の投与時に突起部22の先端が位置すべき部分までの長さとなるように設定される。   In such a configuration, the maximum length H of the protrusion 22 is the difference between the maximum length H of the protrusion 22 and the maximum length T of the elastic member 30, in other words, the elastic member 30 in the normal state in the protrusion 22. The length of the protruding portion is set so as to be the length from the surface of the skin to be administered to the portion where the tip of the protrusion 22 should be positioned when the drug is administered.

なお、薬剤の投与は、弾性部材30が完全に復元してその大きさが通常状態まで戻っている状態で行われる必要はない。すなわち、突起部22を皮膚Skに刺すための押圧力によって弾性部材30が突起部22の延びる方向に最も圧縮されている状態、換言すれば、突起部22が皮膚Skに最も深く刺さっている状態での弾性部材30よりも、押圧力が弱まることに伴って弾性部材30が復元している状態であれば、通常状態よりも弾性部材30が圧縮されている状態で薬剤が投与されてもよい。こうした状態であっても、突起部22が皮膚Skに最も深く刺さっている状態と比較して、皮膚Skにかかる押圧力は弱まっているため、薬剤は皮内へ浸透しやすくなる。   The administration of the drug does not have to be performed in a state where the elastic member 30 is completely restored and its size returns to the normal state. That is, the state in which the elastic member 30 is most compressed in the extending direction of the protrusion 22 by the pressing force for inserting the protrusion 22 into the skin Sk, in other words, the state in which the protrusion 22 is deeply inserted into the skin Sk. The elastic member 30 may be administered in a state where the elastic member 30 is compressed as compared with the normal state as long as the elastic member 30 is restored as the pressing force is weakened. . Even in such a state, since the pressing force applied to the skin Sk is weaker than the state where the protrusion 22 is deeply pierced into the skin Sk, the drug is likely to penetrate into the skin.

この場合、突起部22の最大長Hは、弾性部材30の最大長Tや弾性率、薬剤の投与部位における皮膚の硬さや弾性率、加えられる押圧力等を考慮して、薬剤が投与されている状態において、突起部22の先端が薬剤を投与すべき部位に位置するように、すなわち、突起部22のなかで弾性部材30よりも飛び出て皮膚に刺さっている部分の長さが、薬剤を投与すべき深さとなるように設定されればよい。   In this case, the maximum length H of the protrusion 22 is determined by taking into consideration the maximum length T and elastic modulus of the elastic member 30, the hardness and elastic modulus of the skin at the drug administration site, the applied pressing force, and the like. In the state where the tip of the protrusion 22 is located at the site where the medicine is to be administered, that is, the length of the part of the protrusion 22 that protrudes from the elastic member 30 and pierces the skin is What is necessary is just to set so that it may become the depth which should be administered.

[経皮投与デバイスの材料および製造方法]
上述の経皮投与デバイス10を構成する各部の材料および製造方法について説明する。
マイクロニードル20を構成する材料は特に限定されないが、材料としては、例えば、ポリ乳酸、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、環状ポリオレフィン、ポリスチレン、ポリ−(4−メチルペンテン−1)、ポリカーボネート、アクリル樹脂、アクリロニトリル−ブタジエン−スチレン共重合体、ポリエチレンテレフタレート、ポリエチレンナフタレート等のポリエステル、例えばナイロン6、ナイロン6・6、ナイロン310、ナイロン12等のポリアミド、ブタジエン−スチレン共重合体等の樹脂が用いられる。マイクロニードル20を構成する材料は生体適合性を有することが好ましい。なお、マイクロニードル20は、内部の視認性を確保するために、透明もしくは半透明であることが好ましい。
[Transdermal Device Material and Manufacturing Method]
The material and manufacturing method of each part which comprises the above-mentioned transdermal administration device 10 are demonstrated.
The material constituting the microneedle 20 is not particularly limited. Examples of the material include polylactic acid, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, and acrylic resin. Polyesters such as acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate and polyethylene naphthalate, for example, polyamides such as nylon 6, nylon 6,6, nylon 310, nylon 12, and resins such as butadiene-styrene copolymer are used. . The material constituting the microneedle 20 is preferably biocompatible. The microneedle 20 is preferably transparent or translucent in order to ensure internal visibility.

マイクロニードル20は、全体が一体に形成されていてもよいし、複数の部材の組み付けによって形成されていてもよい。上述の材料を用いてマイクロニードル20を一体に形成するためには、例えば、射出成形、押出成形、インプリント、ホットエンボス、キャスティング等の公知の溶融成形加工技術を用いればよい。貫通孔23は、例えば、マイクロドリル、レーザ加工等の公知の微細加工技術によって形成することができる。   The microneedle 20 may be formed integrally as a whole, or may be formed by assembling a plurality of members. In order to integrally form the microneedle 20 using the above-described material, for example, a known melt molding processing technique such as injection molding, extrusion molding, imprinting, hot embossing, or casting may be used. The through hole 23 can be formed by a known fine processing technique such as micro drilling or laser processing.

また、溶融成形以外のマイクロニードル20の形成方法として、基板に孔を形成した後に、エッチングによって突起部22の外形形状を形成する方法が用いられてもよい。基板への孔の形成には、ウェットエッチング、ドライエッチング、レーザ加工、機械加工等の各種の公知技術を用いることができる。そして、突起部22の形成予定領域で中央部から周縁に向けて厚みが連続的に変化するエッチングマスクを用い、エッチングを行うことによって、基板に針状の構造体を形成する。   Further, as a method for forming the microneedles 20 other than melt molding, a method of forming the outer shape of the protrusion 22 by etching after forming holes in the substrate may be used. Various known techniques such as wet etching, dry etching, laser processing, and machining can be used for forming the holes in the substrate. Then, a needle-like structure is formed on the substrate by performing etching using an etching mask whose thickness continuously changes from the central portion toward the periphery in the region where the protrusion 22 is to be formed.

この場合、マイクロニードル20を構成する材料はウェットエッチングやドライエッチング等のエッチングによって加工可能な材料であればよく、こうした材料としては、例えば、チタン、アルミニウム、ステンレス鋼等の金属や、ポリカーボネート、ポリスチレン、アクリル樹脂、フッ素樹脂等の合成樹脂やシリコン等が挙げられる。   In this case, the material constituting the microneedle 20 may be any material that can be processed by etching such as wet etching or dry etching. Examples of such a material include metals such as titanium, aluminum, and stainless steel, polycarbonate, polystyrene, and the like. , Synthetic resins such as acrylic resin and fluororesin, and silicon.

弾性部材30を構成する材料は、所望の弾性と粘着性とを実現可能な材料であれば特に限定されないが、例えば、ウレタンゲルが用いられることが好ましい。弾性部材30は、例えば、硬度(ショアA)が1以上5以下、30%圧縮強度(N/mm)が10以上100以下、圧縮弾性率(N/mm)が100以上500以下、180°ピール試験の粘着性(N/25mm)が2以上10以下であることが好ましく、弾性部材30の構成材料としてウレタンゲルを用いれば、こうした特性が好適に実現できる。こうしたウレタンゲルとしては、例えば、エクシール社製のゲルタックシートが用いられ、シートが円環状に打ち抜かれることによって弾性部材30が形成される。 Although the material which comprises the elastic member 30 will not be specifically limited if it is a material which can implement | achieve desired elasticity and adhesiveness, For example, it is preferable that a urethane gel is used. The elastic member 30 has, for example, a hardness (Shore A) of 1 or more and 5 or less, a 30% compressive strength (N / mm 2 ) of 10 or more and 100 or less, and a compression elastic modulus (N / mm 2 ) of 100 or more and 500 or less, 180 ° Peel test adhesiveness (N / 25 mm) is preferably 2 or more and 10 or less, and if urethane gel is used as a constituent material of the elastic member 30, such characteristics can be suitably realized. As such a urethane gel, for example, a gel tack sheet manufactured by Exceal is used, and the elastic member 30 is formed by punching the sheet into an annular shape.

[弾性部材の形状および配置の変形例]
図6〜図43を参照して、弾性部材30の形状および配置の変形例について説明する。なお、図6〜図36においては、弾性部材30をドットを付して示している。
上記形態の弾性部材30は、径方向の幅が一定である円環状を有しているが、弾性部材30は、複数の突起部22からなる集合を取り囲んでいればよく、支持面21Sと対向する方向から見て弾性部材30に囲まれる領域は円形でなくてもよい。
[Modification of shape and arrangement of elastic member]
A modification of the shape and arrangement of the elastic member 30 will be described with reference to FIGS. 6 to 36, the elastic member 30 is shown with dots.
The elastic member 30 having the above-described configuration has an annular shape with a constant radial width, but the elastic member 30 only needs to surround a set of the plurality of protrusions 22 and is opposed to the support surface 21S. The region surrounded by the elastic member 30 as viewed from the direction to be not necessarily circular.

例えば、弾性部材30が囲む領域は、図6が示すように、略矩形状であってもよいし、図7が示すように、突起部22の配置に応じて湾曲する縁部を有する形状であってもよい。要は、支持面21Sと対向する方向から見て、弾性部材30は、その中央に、複数の突起部22が配置されている領域よりも大きい領域を区画していればよい。換言すれば、弾性部材30は、複数の突起部22が配置されている領域よりも大きな開口を有していればよい。   For example, the region surrounded by the elastic member 30 may have a substantially rectangular shape as shown in FIG. 6, or a shape having an edge that curves according to the arrangement of the protrusions 22 as shown in FIG. 7. There may be. In short, as viewed from the direction facing the support surface 21S, the elastic member 30 only needs to define an area larger than the area where the plurality of protrusions 22 are arranged at the center. In other words, the elastic member 30 should just have an opening larger than the area | region where the some projection part 22 is arrange | positioned.

また、上記各形態では、弾性部材30は、複数の突起部22の集合を取り囲んでいたが、図8や図9が示すように、弾性部材30は、複数の突起部22を1つずつ個別に取り囲んでいてもよい。すなわち、弾性部材30は複数の突起部22の各々の配置位置に、各突起部22の配置されている領域よりも大きな開口を有していてもよい。   In each of the above embodiments, the elastic member 30 surrounds a set of the plurality of protrusions 22, but as shown in FIGS. 8 and 9, the elastic member 30 individually includes the plurality of protrusions 22 one by one. It may be surrounded by That is, the elastic member 30 may have an opening larger than the area where each protrusion 22 is arranged at each arrangement position of the plurality of protrusions 22.

弾性部材30が複数の突起部22を1つずつ取り囲んでいる構成では、弾性部材30が複数の突起部22の集合を取り囲んでいる構成と比較して、支持面21Sにおいて弾性部材30が占有する面積を大きく確保しやすい。したがって、薬剤の投与に際して、皮膚に貼り付く弾性部材30の面積を大きく確保しやすいため、薬剤の投与中における皮膚に対する突起部22の位置の安定性が高められる。   In the configuration in which the elastic member 30 surrounds the plurality of protrusions 22 one by one, the elastic member 30 occupies the support surface 21 </ b> S compared to the configuration in which the elastic member 30 surrounds the set of the plurality of protrusions 22. It is easy to secure a large area. Therefore, since the area of the elastic member 30 that adheres to the skin can be easily secured during the administration of the drug, the stability of the position of the protrusion 22 relative to the skin during the administration of the drug is improved.

また、本実施形態の経皮投与デバイス10を用いて薬剤の投与が行われる場合、弾性部材30が皮膚に貼り付いていることにより、皮膚が弾性部材30に軽く押さえられているため、皮膚が弛むことが抑えられ、突起部22が所望の深さまで刺さりやすい。弾性部材30が複数の突起部22を1つずつ取り囲んでいる構成では、こうした皮膚の弛みを抑える効果を高く得られる。皮膚の弛みの程度は、肢体における薬剤の投与部位や、投与対象の年齢等によっても変わるため、投与対象の投与部位に応じて、弾性部材30が複数の突起部22を1つずつ取り囲んでいる構成、もしくは、複数の突起部22の集合を取り囲んでいる構成が選択されるとともに、支持面21Sにおける弾性部材30の配置面積が設定されることが好ましい。   In addition, when a drug is administered using the transdermal administration device 10 according to the present embodiment, the skin is lightly pressed by the elastic member 30 because the elastic member 30 is attached to the skin. The loosening is suppressed, and the protrusion 22 is easily stuck to a desired depth. In the configuration in which the elastic member 30 surrounds the plurality of protrusions 22 one by one, the effect of suppressing such skin sag can be obtained. The degree of skin sag varies depending on the administration site of the drug in the limbs, the age of the administration target, and the like. Therefore, the elastic member 30 surrounds the plurality of protrusions 22 one by one according to the administration site of the administration target. It is preferable that the configuration or the configuration surrounding the set of the plurality of protrusions 22 is selected and the arrangement area of the elastic member 30 on the support surface 21S is set.

なお、上記各形態では、支持面21Sの中央部分に1つの突起部22が位置し、この突起部22を囲む円環上に、複数の突起部22が配置されているが、支持面21Sの中央部には、突起部22が配置されていなくてもよい。   In each of the above embodiments, one protrusion 22 is located at the center of the support surface 21S, and a plurality of protrusions 22 are disposed on the ring surrounding the protrusion 22, but the support surface 21S The protrusion 22 may not be arranged at the center.

例えば、図10が示すように、支持面21Sの中央部には突起部22が配置されず、中央部を囲む外周部にて1つの環上に複数の突起部22が配置され、弾性部材30が複数の突起部22の集合を取り囲んでいてもよい。この場合、支持面21Sの中央部には、突起部22も弾性部材30も配置されていない。また例えば、図11が示すように、支持面21Sの中央部には突起部22が配置されず、外周部にて1つの環上に複数の突起部22が配置され、弾性部材30が複数の突起部22を1つずつ取り囲んでいてもよい。この場合、支持面21Sの中央部には、弾性部材30が配置されている。   For example, as illustrated in FIG. 10, the protrusion 22 is not disposed at the center of the support surface 21 </ b> S, and a plurality of protrusions 22 are disposed on one ring at the outer periphery surrounding the center, and the elastic member 30. May surround a set of a plurality of protrusions 22. In this case, neither the protrusion part 22 nor the elastic member 30 is arrange | positioned in the center part of 21 S of support surfaces. Further, for example, as shown in FIG. 11, the protrusion 22 is not disposed at the center portion of the support surface 21 </ b> S, the plurality of protrusions 22 are disposed on one ring at the outer peripheral portion, and the elastic member 30 includes a plurality of elastic members 30. The protrusions 22 may be surrounded one by one. In this case, the elastic member 30 is disposed at the center of the support surface 21S.

こうした構成によれば、支持面21Sにおける外周部のみに突起部22が配置されているため、支持面21Sの中央部と外周部とで、突起部22の穿刺に際してこれらの部位にかかる押圧力の大きさが異なっていたり、支持面21Sと対向する皮膚の弾性等の特性が異なっていたりしても、各突起部22が皮膚に刺さる深さにばらつきが生じることが抑えられる。   According to such a configuration, since the protrusions 22 are disposed only on the outer peripheral portion of the support surface 21S, the pressing force applied to these portions when the protrusion 22 is punctured between the central portion and the outer peripheral portion of the support surface 21S. Even if the sizes are different or the characteristics such as the elasticity of the skin facing the support surface 21S are different, it is possible to suppress variations in the depth at which each protrusion 22 pierces the skin.

また、マイクロニードル20の備える突起部22が1つである場合、弾性部材30が囲む領域は、図12や図13が示すように、突起部22の1つのみを配置可能な大きさの領域であってもよいし、図14が示すように、突起部22の1つのみを配置可能な大きさよりも大きな領域であってもよい。支持面21Sと対向する方向から見て、弾性部材30が囲む領域は、図12が示すように、突起部22と相似形状であってもよいし、図13や図14が示すように、相似形状とは異なる形状であってもよい。
上記各形態では、突起部22の形状が略円錐形状である構成を例示したが、突起部22が他の形状である場合にも、同様の弾性部材30が配置されればよい。
Moreover, when the projection part 22 with which the microneedle 20 is provided is one, the area | region which the elastic member 30 surrounds is an area | region of the magnitude | size which can arrange | position only one projection part 22, as FIG.12 and FIG.13 shows. Alternatively, as shown in FIG. 14, the area may be larger than a size where only one of the protrusions 22 can be arranged. When viewed from the direction facing the support surface 21S, the region surrounded by the elastic member 30 may be similar to the protrusion 22 as shown in FIG. 12, or similar as shown in FIG. 13 and FIG. The shape may be different from the shape.
In each of the above embodiments, the configuration in which the shape of the protruding portion 22 is a substantially conical shape has been illustrated, but the same elastic member 30 may be disposed even when the protruding portion 22 has another shape.

例えば、突起部22が略四角錐形状である場合にも、弾性部材30は、図15や図16が示すように、複数の突起部22からなる集合を取り囲んでいてもよいし、図17や図18が示すように、複数の突起部22を1つずつ取り囲んでいてもよい。   For example, even when the protrusion 22 has a substantially quadrangular pyramid shape, the elastic member 30 may surround a set of the plurality of protrusions 22 as shown in FIG. 15 and FIG. As shown in FIG. 18, the plurality of protrusions 22 may be surrounded one by one.

また、弾性部材30が区画する領域が所定のマークや絵柄、文字等を構成していてもよい。
例えば、図19〜図21が示す例では、支持面21Sには、その中央部に1つの突起部22が配置され、この中央の突起部22を囲む円環上に、複数の突起部22が位置している。そして、弾性部材30が囲む領域は、中央の突起部22を囲んでいる突起部22の数と同じ数の突出した頂点を有する星形形状を有している。
Moreover, the area | region which the elastic member 30 partitions may comprise the predetermined | prescribed mark, a pattern, a character, etc.
For example, in the example shown in FIGS. 19 to 21, the support surface 21 </ b> S is provided with one protrusion 22 at the center thereof, and a plurality of protrusions 22 are formed on the ring surrounding the center protrusion 22. positioned. The region surrounded by the elastic member 30 has a star shape having the same number of protruding vertices as the number of the protruding portions 22 surrounding the central protruding portion 22.

また例えば、図22が示す例では、支持面21Sには、その外周部における1つの円環上に複数の突起部22が位置している。弾性部材30は、各突起部22の配置されている領域に三角形状の領域を区画して複数の突起部22を突起部22ごとに取り囲むとともに、その中央に形成された開口等によって、全体として太陽風の絵柄を構成している。   Further, for example, in the example shown in FIG. 22, a plurality of protrusions 22 are located on one annular ring on the outer peripheral portion of the support surface 21 </ b> S. The elastic member 30 divides a triangular area in the area where each protrusion 22 is arranged, surrounds the plurality of protrusions 22 for each protrusion 22, and as a whole by an opening or the like formed in the center thereof. Constructs a sun-inspired pattern.

また、支持面21Sには、特性の異なる二種類の弾性部材30である第1弾性部材31と第2弾性部材32とが配置されていてもよい。例えば、第1弾性部材31と第2弾性部材32とは、弾性率の大きさ、粘着性の強さ、および、弾性部材30の最大長Tの少なくとも1つが異なる。   The first elastic member 31 and the second elastic member 32, which are two types of elastic members 30 having different characteristics, may be disposed on the support surface 21S. For example, the first elastic member 31 and the second elastic member 32 are different in at least one of the magnitude of elastic modulus, the strength of adhesiveness, and the maximum length T of the elastic member 30.

図23や図24が示すように、例えば、第1弾性部材31は、支持面21Sの外縁に沿って配置されて複数の突起部22の集合を取り囲み、第2弾性部材32は、支持面21Sの中央に位置する突起部22を取り囲む位置に配置される。第1弾性部材31が囲む領域の形状と第2弾性部材32が囲む領域の形状とは、上記各形態における弾性部材30と同様に特に限定されない。   As shown in FIGS. 23 and 24, for example, the first elastic member 31 is disposed along the outer edge of the support surface 21S and surrounds a set of the plurality of protrusions 22, and the second elastic member 32 is provided with the support surface 21S. It arrange | positions in the position which surrounds the projection part 22 located in the center. The shape of the region surrounded by the first elastic member 31 and the shape of the region surrounded by the second elastic member 32 are not particularly limited as in the elastic member 30 in each of the above embodiments.

第1弾性部材31と第2弾性部材32との特性は、例えば、突起部22が受ける押圧力の位置によるばらつきや、薬剤の投与部位内での皮膚の伸びやすさのばらつき等に応じて設定される。   The characteristics of the first elastic member 31 and the second elastic member 32 are set according to, for example, variation due to the position of the pressing force received by the protrusion 22 or variation in the easiness of skin elongation within the drug administration site. Is done.

例えば、基体部21の形状や突起部22の配置等に起因して、支持面21Sの中央部に位置する突起部22よりも外周部に位置する突起部22の方が大きな押圧力を受ける場合がある。この場合には、支持面21Sの中央部に位置する突起部22よりも外周部に位置する突起部22の方が皮膚に深く刺さりやすい。そこで、支持面21Sの外周部に位置する第1弾性部材31を、支持面21Sの中央部に位置する第2弾性部材32よりも弾性率の大きい弾性体とし、相対的に大きな押圧力を受けて圧縮された第1弾性部材31の厚みと、相対的に小さな押圧力を受けて圧縮された第2弾性部材32の厚みとが同程度になるように、各弾性部材31,32の弾性率を調整する。これにより、突起部22の位置によって受ける押圧力の大きさに違いがある場合でも、各突起部22が皮膚に刺さる深さがばらつくことが抑えられる。   For example, due to the shape of the base portion 21 and the arrangement of the protrusions 22, the protrusion 22 positioned on the outer peripheral portion receives a greater pressing force than the protrusion 22 positioned at the center of the support surface 21 </ b> S. There is. In this case, the protrusion 22 positioned on the outer peripheral portion is more likely to pierce the skin deeper than the protrusion 22 positioned in the center of the support surface 21S. Therefore, the first elastic member 31 located on the outer peripheral portion of the support surface 21S is made an elastic body having a larger elastic modulus than the second elastic member 32 located on the center portion of the support surface 21S, and receives a relatively large pressing force. The elastic modulus of each elastic member 31, 32 is such that the thickness of the compressed first elastic member 31 and the thickness of the second elastic member 32 compressed by receiving a relatively small pressing force are approximately the same. Adjust. Thereby, even when there is a difference in the magnitude of the pressing force received depending on the position of the protrusion 22, it is possible to prevent the depth at which each protrusion 22 pierces the skin from varying.

また例えば、支持面21Sと対向する薬剤の投与部位においては、その中央部よりも外周部の方が皮膚が伸びやすく、押圧力を受けて中央部よりも外周部での皮膚の伸びが大きい状態で突起部22が刺さると、押圧力が弱められたときに中央部よりも外周部の方が皮膚に深く突起部22が刺さった状態となる場合がある。そこで、押圧力を受けて突起部22が皮膚に最も深く刺さった状態において、支持面21Sの外周部に位置する突起部22が支持面21Sの中央部に位置する突起部22よりも皮膚に浅く刺さるようにする。すなわち、第1弾性部材31を第2弾性部材32よりも弾性率の大きい弾性体とするか、もしくは、第1弾性部材31を第2弾性部材32よりも最大長Tの大きい弾性体として、押圧力を受けて突起部22が皮膚に最も深く刺さった状態において、第1弾性部材31の厚みが第2弾性部材32の厚みよりも大きくなるようにする。これにより、押圧力が弱められて皮膚の伸びが戻った状態において、各突起部22が皮膚に刺さる深さがばらつくことが抑えられる。   Further, for example, in the administration site of the drug facing the support surface 21S, the skin is more easily stretched at the outer peripheral portion than at the central portion, and the skin is stretched more at the outer peripheral portion than at the central portion due to the pressing force. When the protruding portion 22 is pierced, there is a case where the protruding portion 22 pierces the skin deeper in the outer peripheral portion than in the central portion when the pressing force is weakened. Therefore, in a state where the protrusion 22 is deeply stabbed into the skin due to the pressing force, the protrusion 22 located on the outer periphery of the support surface 21S is shallower than the protrusion 22 located at the center of the support surface 21S. Try to sting. That is, the first elastic member 31 is an elastic body having a larger elastic modulus than that of the second elastic member 32, or the first elastic member 31 is an elastic body having a maximum length T larger than that of the second elastic member 32. The thickness of the first elastic member 31 is set to be greater than the thickness of the second elastic member 32 in a state where the protrusion 22 is deeply stabbed into the skin under pressure. Thereby, in a state where the pressing force is weakened and the skin stretches back, it is possible to prevent the depth at which each protrusion 22 pierces the skin from varying.

なお、こうした支持面21Sの中央部と外周部とでの突起部22の配置位置の違いによる突起部22の皮膚に刺さる深さのばらつきを抑えるための構成としては、上述のように特性の異なる二種類の弾性部材30を配置する構成の他に、先の図10や図11に示したように、支持面21Sの外周部のみに突起部22が配置された構成も好適に利用できる。   In addition, as a structure for suppressing the dispersion | variation in the depth stuck in the skin of the projection part 22 by the difference in the arrangement position of the projection part 22 in the center part of this support surface 21S and an outer peripheral part, a characteristic differs as mentioned above. In addition to the configuration in which the two types of elastic members 30 are disposed, a configuration in which the protrusions 22 are disposed only on the outer peripheral portion of the support surface 21S can be suitably used as shown in FIGS.

また、第1弾性部材31と第2弾性部材32との粘着性を異ならせることによって、支持面21S内での位置に応じて、経皮投与デバイス10が皮膚に貼り付く強さを調整してもよい。例えば、投与部位のなかで外側に位置する部分ほど、弾性部材が剥がれやすくなる傾向がある。これに対し、第1弾性部材31の粘着性が、第2弾性部材32の粘着性よりも大きい構成であれば、支持面21Sの中央部と対向する部分よりも、支持面21Sの外周部と対向する部分にて、皮膚に経皮投与デバイス10が強く貼り付くため、薬剤の投与前および投与中において、経皮投与デバイス10が皮膚から剥がれることが抑えられる。   Further, by making the first elastic member 31 and the second elastic member 32 different in adhesiveness, the strength with which the transdermal administration device 10 sticks to the skin is adjusted according to the position in the support surface 21S. Also good. For example, the elastic member tends to be peeled off as the portion located on the outer side in the administration site is increased. On the other hand, if the adhesiveness of the first elastic member 31 is greater than the adhesiveness of the second elastic member 32, the outer peripheral portion of the support surface 21S and the portion facing the central portion of the support surface 21S Since the transdermal administration device 10 sticks strongly to the skin at the facing portion, the transdermal administration device 10 can be prevented from peeling off from the skin before and during the administration of the drug.

第1弾性部材31と第2弾性部材32との各々の形状や数は、第1弾性部材31と第2弾性部材32との間で異ならせる特性およびその目的に応じて設定されればよい。また、上記例以外にも、例えば、支持面21S内の位置によって突起部22の皮膚に刺さる深さを変えたい場合や、支持面21S内の位置によって突起部22の最大長Hが異なる場合等にも、目的に応じて、特性の異なる二種類の弾性部材30が用いられてもよい。さらに、支持面21Sには、特性の異なる三種類以上の弾性部材30が配置されてもよい。なお、支持面21Sに配置された複数の弾性部材30は、弾性率の大きさ、粘着性の強さ、および、弾性部材30の最大長Tのうちの2つ以上が異なる弾性部材30であってもよい。   The shape and number of each of the first elastic member 31 and the second elastic member 32 may be set according to the characteristics that are different between the first elastic member 31 and the second elastic member 32 and the purpose thereof. In addition to the above example, for example, when it is desired to change the depth of the protrusion 22 in the skin depending on the position within the support surface 21S, or when the maximum length H of the protrusion 22 varies depending on the position within the support surface 21S, etc. In addition, two types of elastic members 30 having different characteristics may be used depending on the purpose. Further, three or more types of elastic members 30 having different characteristics may be disposed on the support surface 21S. The plurality of elastic members 30 arranged on the support surface 21S are elastic members 30 in which two or more of the magnitude of the elastic modulus, the adhesive strength, and the maximum length T of the elastic member 30 are different. May be.

また、弾性部材30は、支持面21Sに位置していれば、単独で突起部22を取り囲んでいなくてもよいし、支持面21Sの外縁に沿って配置されていなくてもよい。   Further, as long as the elastic member 30 is positioned on the support surface 21S, the elastic member 30 may not surround the protrusion 22 alone, and may not be disposed along the outer edge of the support surface 21S.

例えば、図25や図26が示すように、支持面21Sに複数の弾性部材30が配置され、弾性部材30は、複数の突起部22の間の領域に位置していてもよい。支持面21Sにて複数の突起部22が支持面21Sの中央部を中心として均等に並んでいる場合には、複数の弾性部材30も、支持面21Sの中央部を中心として均等に並んでいることが好ましい。弾性部材30の形状や数は、複数の突起部22の配置態様に応じて適宜設定されればよい。   For example, as shown in FIG. 25 and FIG. 26, a plurality of elastic members 30 may be arranged on the support surface 21 </ b> S, and the elastic members 30 may be located in a region between the plurality of protrusions 22. When the plurality of protrusions 22 are evenly arranged around the center of the support surface 21S on the support surface 21S, the plurality of elastic members 30 are also equally arranged around the center of the support surface 21S. It is preferable. The shape and number of the elastic members 30 may be set as appropriate according to the arrangement of the plurality of protrusions 22.

また、弾性部材30が単独で突起部22を取り囲んでいない場合においても、支持面21Sには、特性の異なる二種類以上の弾性部材30が配置されていてもよい。   Even when the elastic member 30 does not surround the protrusion 22 alone, two or more types of elastic members 30 having different characteristics may be arranged on the support surface 21S.

例えば、図27や図28が示すように、支持面21Sの外周部に複数の第1弾性部材31が配置され、第1弾性部材31が配置されている領域よりも内側の領域に、複数の第2弾性部材32が配置される。   For example, as shown in FIG. 27 and FIG. 28, a plurality of first elastic members 31 are arranged on the outer peripheral portion of the support surface 21 </ b> S, and a plurality of regions are arranged in a region inside the region where the first elastic members 31 are arranged. The second elastic member 32 is disposed.

上記各形態では、支持面21Sの形状が円形状である構成を例示したが、基体部21の形状に応じて、支持面21Sは、矩形形状であってもよいし、楕円形状であってもよい。支持面21Sの形状に関わらず、弾性部材30は上記形態と同様に配置されればよい。   In each of the above embodiments, the configuration in which the shape of the support surface 21S is circular has been illustrated, but the support surface 21S may be rectangular or elliptical depending on the shape of the base portion 21. Good. Regardless of the shape of the support surface 21S, the elastic member 30 may be arranged in the same manner as in the above embodiment.

例えば、図29〜図36は、支持面21Sが楕円形状を有する例を示す。図29や図30が示すように、弾性部材30は、複数の突起部22からなる集合を取り囲んでいてもよいし、図31や図32が示すように、弾性部材30は、複数の突起部22を1つずつ取り囲んでいてもよい。また例えば、図33〜36が示すように、弾性部材30は、単独で突起部22を取り囲んでおらず、支持面21Sに複数の弾性部材30が配置されていてもよい。図33や図34が示すように、弾性部材30は、複数の突起部22の間に配置されていてもよいし、図35や図36が示すように、弾性部材30は、複数の突起部22の周りに配置されていてもよい。また例えば、支持面21Sには、特性の異なる二種類の弾性部材30が配置されていてもよい。   For example, FIGS. 29 to 36 show examples in which the support surface 21S has an elliptical shape. As shown in FIGS. 29 and 30, the elastic member 30 may surround a set of a plurality of protrusions 22, and as shown in FIGS. 31 and 32, the elastic member 30 includes a plurality of protrusions. 22 may be surrounded one by one. For example, as FIG. 33-36 shows, the elastic member 30 does not surround the projection part 22 independently, and the some elastic member 30 may be arrange | positioned at the support surface 21S. As shown in FIGS. 33 and 34, the elastic member 30 may be disposed between the plurality of protrusions 22, and as shown in FIGS. 35 and 36, the elastic member 30 includes a plurality of protrusions. It may be arranged around 22. For example, two types of elastic members 30 having different characteristics may be arranged on the support surface 21S.

なお、図29〜図36では、突起部22の形状が略四角錐形状である構成を例示したが、支持面21Sの形状に関わらず、突起部22の形状は、上述のように、皮膚を刺すことの可能な形状であればよい。   29 to 36 exemplify a configuration in which the shape of the protruding portion 22 is a substantially quadrangular pyramid shape, but the shape of the protruding portion 22 is not limited to the shape of the supporting surface 21S, as described above. Any shape that can be stabbed is acceptable.

また、先の図1〜図3を参照して説明した形態では、突起部22の延びる方向における弾性部材30の長さは、弾性部材30のなかで一定であるが、弾性部材30の長さは、弾性部材30のなかで変化していてもよい。すなわち、弾性部材30は、弾性部材30の長さが各々で異なる複数の部位を有していてもよい。   In the embodiment described with reference to FIGS. 1 to 3, the length of the elastic member 30 in the direction in which the protrusion 22 extends is constant in the elastic member 30. May change in the elastic member 30. That is, the elastic member 30 may have a plurality of portions in which the length of the elastic member 30 is different from each other.

例えば、図37や図38が示すように、弾性部材30は、複数の突起部22の集合を取り囲む環状を有し、径方向の外側から内側に向かって、突起部22の延びる方向における弾性部材30の長さが徐々に小さくなる部分を有していてもよい。換言すれば、支持面21Sと対向する方向から見て、弾性部材30は、弾性部材30の内周縁に向けて支持面21Sに近づく傾斜面を有していてもよい。   For example, as shown in FIGS. 37 and 38, the elastic member 30 has an annular shape surrounding a set of the plurality of protrusions 22, and is an elastic member in a direction in which the protrusions 22 extend from the outside in the radial direction to the inside. You may have the part which length of 30 becomes small gradually. In other words, when viewed from the direction facing the support surface 21S, the elastic member 30 may have an inclined surface that approaches the support surface 21S toward the inner peripheral edge of the elastic member 30.

こうした構成によれば、例えば、以下の効果が得られる。すなわち、経皮投与デバイス10が皮膚に押し付けられた後、その押圧力が弱められたときに、弾性部材30の傾斜面に皮膚の表面が貼り付くことにより、傾斜面と突起部22との間の空間に皮膚が入るように皮膚が持ち上げられる。したがって、突起部22の周囲で皮膚が持ち上げられるため、薬剤の漏れや経皮投与デバイス10が皮膚から剥がれることが抑えられる。   According to such a configuration, for example, the following effects can be obtained. In other words, after the transdermal administration device 10 is pressed against the skin, when the pressing force is weakened, the skin surface sticks to the inclined surface of the elastic member 30, so that the gap between the inclined surface and the protrusion 22 is reduced. The skin is lifted so that the skin enters the space. Therefore, since the skin is lifted around the protrusion 22, it is possible to suppress leakage of the drug and peeling of the transdermal administration device 10 from the skin.

突起部22の延びる方向に対する傾斜面の傾斜角度は投与部位における皮膚の伸びやすさ等に応じて適宜設定されればよい。また、傾斜面は、例えば、図37に示す例のように平面であってもよいし、図38に示す例のように曲面であってもよい。また、図37および図38では、突起部22の延びる方向における弾性部材30の長さは、弾性部材30の径方向の外側から内側に向かって、一定に推移した後、徐々に小さくなる。すなわち、支持面21Sと対向する方向から見える弾性部材30は、支持面21Sと平行な平面と上記傾斜面とから構成されるが、弾性部材30はこうした平面を有していなくともよく、弾性部材30の長さは、その径方向の外側から内側に向かって、常に徐々に小さくなってもよい。   The inclination angle of the inclined surface with respect to the extending direction of the protrusion 22 may be set as appropriate according to the ease of extension of the skin at the administration site. Further, the inclined surface may be a flat surface as in the example shown in FIG. 37, or may be a curved surface as in the example shown in FIG. In FIGS. 37 and 38, the length of the elastic member 30 in the extending direction of the protruding portion 22 becomes constant from the radially outer side to the inner side of the elastic member 30 and then gradually decreases. That is, the elastic member 30 seen from the direction facing the support surface 21S is composed of a plane parallel to the support surface 21S and the inclined surface, but the elastic member 30 does not have to have such a plane. The length of 30 may always gradually decrease from the outside in the radial direction toward the inside.

また、突起部22の延びる方向に、複数の弾性部材30が積層されていてもよい。例えば、図39が示す例では、支持面21Sに近い位置から順に、各々が環状であって複数の突起部22の集合を取り囲む弾性部材30である第1弾性部材33、第2弾性部材34、第3弾性部材35が並んでいる。そして、支持面21Sと対向する方向から見て、各弾性部材33,34,35の外周縁は一致しており、各弾性部材33,34,35の内周縁は、支持面21Sに近い弾性部材30ほど、内側に位置している。すなわち、支持面21Sと対向する方向から見て、径方向の外側から順に、第3弾性部材35の内周縁、第2弾性部材34の内周縁、第1弾性部材33の内周縁が位置している。   A plurality of elastic members 30 may be stacked in the direction in which the protrusion 22 extends. For example, in the example shown in FIG. 39, the first elastic member 33, the second elastic member 34, which are the elastic members 30 each of which is annular and surrounds the set of the plurality of protrusions 22, in order from the position close to the support surface 21S. The third elastic members 35 are arranged. When viewed from the direction facing the support surface 21S, the outer peripheral edges of the elastic members 33, 34, and 35 match, and the inner peripheral edges of the elastic members 33, 34, and 35 are elastic members close to the support surface 21S. About 30 are located inside. That is, as viewed from the direction facing the support surface 21S, the inner peripheral edge of the third elastic member 35, the inner peripheral edge of the second elastic member 34, and the inner peripheral edge of the first elastic member 33 are located in order from the outside in the radial direction. Yes.

こうした構成によっても、先の図37や図38に示したように、弾性部材30が、径方向の外側から内側に向かって、突起部22の延びる方向における長さが徐々に小さくなる部分を有する構成と同様の効果が得られる。また、複数の弾性部材30に、弾性率や粘着性等の特性が互いに異なる弾性部材30が含まれていてもよい。こうした構成によれば、経皮投与デバイス10が皮膚に押し付けられたときの弾性部材30の積層体における圧縮形状や皮膚への貼り付き方を細かく調整することができる。   Even with such a configuration, as shown in FIGS. 37 and 38, the elastic member 30 has a portion in which the length in the extending direction of the protrusion 22 gradually decreases from the outer side in the radial direction to the inner side. The same effect as the configuration can be obtained. The plurality of elastic members 30 may include elastic members 30 having different properties such as elastic modulus and adhesiveness. According to such a structure, the compression shape in the laminated body of the elastic member 30 when the transdermal administration device 10 is pressed against the skin and how to stick to the skin can be finely adjusted.

また、図40が示すように、弾性部材30は、径方向の内側から外側に向かって、突起部22の延びる方向における弾性部材30の長さが徐々に小さくなる部分を有していてもよい。換言すれば、支持面21Sと対向する方向から見て、弾性部材30は、弾性部材30の外周縁に向けて支持面21Sに近づく傾斜面を有していてもよい。   As shown in FIG. 40, the elastic member 30 may have a portion in which the length of the elastic member 30 in the extending direction of the protrusion 22 gradually decreases from the inner side to the outer side in the radial direction. . In other words, the elastic member 30 may have an inclined surface that approaches the support surface 21S toward the outer peripheral edge of the elastic member 30 when viewed from the direction facing the support surface 21S.

こうした構成によれば、例えば、以下の効果が得られる。すなわち、弾性部材30の外周縁付近では、弾性部材30による皮膚の圧迫が弱められるため、投与部位のなかで皮膚が伸びやすい外周部にて皮膚が過度に延びることが抑えられ、投与部位内において皮膚の伸びの程度がばらつくことが抑えられる。   According to such a configuration, for example, the following effects can be obtained. That is, in the vicinity of the outer peripheral edge of the elastic member 30, the pressure of the skin by the elastic member 30 is weakened, so that it is possible to prevent the skin from extending excessively at the outer peripheral portion where the skin is easily stretched in the administration site. Variations in the degree of skin elongation can be suppressed.

なお、突起部22の延びる方向に対する傾斜面の傾斜角度は投与部位における皮膚の伸びやすさ等に応じて適宜設定されればよいし、傾斜面は平面であっても曲面であってもよい。また、弾性部材30は、図40に示す例のように、突起部22の延びる方向における弾性部材30の長さが一定である部分を有していてもよいし、有していなくてもよい。すなわち、支持面21Sと対向する方向から見える弾性部材30は、支持面21Sと平行な平面と上記傾斜面とから構成されてもよいし、弾性部材30はこうした平面を有していなくともよく、弾性部材30の長さは、その径方向の内側から外側に向かって、常に徐々に小さくなってもよい。   In addition, the inclination angle of the inclined surface with respect to the extending direction of the protrusion 22 may be appropriately set according to the ease of elongation of the skin at the administration site, and the inclined surface may be a flat surface or a curved surface. The elastic member 30 may or may not have a portion where the length of the elastic member 30 in the extending direction of the protrusion 22 is constant as in the example shown in FIG. . That is, the elastic member 30 seen from the direction facing the support surface 21S may be configured by a plane parallel to the support surface 21S and the inclined surface, or the elastic member 30 may not have such a plane. The length of the elastic member 30 may always gradually decrease from the inside in the radial direction toward the outside.

また、図41が示すように、弾性部材30は、突起部22の延びる方向における弾性部材30の長さが、径方向の外側から内側に向かって徐々に小さくなる部分と、径方向の内側から外側に向かって徐々に小さくなる部分とを有していてもよい。換言すれば、支持面21Sと対向する方向から見て、弾性部材30は、弾性部材30の内周縁に向けて支持面21Sに近づく傾斜面と、弾性部材30の外周縁に向けて支持面21Sに近づく傾斜面とを有していてもよい。図41に示す例では、突起部22の延びる方向における弾性部材30の長さは、弾性部材30の径方向の外側から内側に向かって、徐々に大きくなった後、一定に推移し、その後、徐々に小さくなっている。なお、弾性部材30は、弾性部材30の長さが一定である部分を有していなくてもよく、すなわち、支持面21Sと対向する方向から見て、弾性部材30は、支持面21Sと平行な平面を有していなくてもよい。   As shown in FIG. 41, the elastic member 30 includes a portion where the length of the elastic member 30 in the extending direction of the protrusion 22 gradually decreases from the outer side in the radial direction and the inner side in the radial direction. You may have the part which becomes small gradually toward the outer side. In other words, when viewed from the direction facing the support surface 21 </ b> S, the elastic member 30 has an inclined surface that approaches the support surface 21 </ b> S toward the inner peripheral edge of the elastic member 30, and the support surface 21 </ b> S toward the outer peripheral edge of the elastic member 30. It may have an inclined surface approaching. In the example shown in FIG. 41, the length of the elastic member 30 in the extending direction of the protrusion 22 gradually increases from the radial direction outer side to the inner side of the elastic member 30 and then remains constant. It is getting smaller gradually. The elastic member 30 may not have a portion where the length of the elastic member 30 is constant, that is, the elastic member 30 is parallel to the support surface 21S when viewed from the direction facing the support surface 21S. It is not necessary to have a flat surface.

また、図42や図43が示すように、弾性部材30が、支持面21Sと対向する位置に傾斜面を有することによって、突起部22の延びる方向における弾性部材30の長さが、径方向の外側から内側に向かって徐々に小さくなる部分や径方向の内側から外側に向かって徐々に小さくなる部分が形成されていてもよい。図42や図43が示す例では、弾性部材30は、支持面21Sと対向する方向から見て、弾性部材30の内周縁に向けて支持面21Sに近づく傾斜面と、弾性部材30の外周縁に向けて支持面21Sに近づく傾斜面とを有するとともに、支持面21Sと対向する位置に、弾性部材30の内周縁に向けて支持面21Sから離れる傾斜面と、弾性部材30の外周縁に向けて支持面21Sから離れる傾斜面とを有する。   42 and 43, the elastic member 30 has an inclined surface at a position facing the support surface 21S, so that the length of the elastic member 30 in the extending direction of the protrusion 22 is the radial direction. A portion that gradually decreases from the outside to the inside or a portion that gradually decreases from the inside in the radial direction to the outside may be formed. 42 and 43, the elastic member 30 includes an inclined surface that approaches the support surface 21S toward the inner periphery of the elastic member 30 and an outer periphery of the elastic member 30 when viewed from the direction facing the support surface 21S. Toward the support surface 21S, toward the inner peripheral edge of the elastic member 30, toward the inner peripheral edge of the elastic member 30, and toward the outer peripheral edge of the elastic member 30. And an inclined surface separated from the support surface 21S.

これらの傾斜面は、突起部22の延びる方向に沿った断面において、図42が示すように、突起部22の延びる方向に沿った直線およびこの方向と直交する方向に沿った直線の各々に対して線対称に配置されていてもよいし、図43が示すように、これらの直線の各々に対して非対称に配置されていてもよい。
また、これら図42や図43に示す例のように、支持面21Sと対向する方向から見て、弾性部材30は支持面21Sの外縁からはみ出していてもよい。
As shown in FIG. 42, these inclined surfaces in the cross section along the extending direction of the protruding portion 22, with respect to each of the straight line along the extending direction of the protruding portion 22 and the straight line along the direction orthogonal to this direction. As shown in FIG. 43, they may be arranged asymmetrically with respect to each of these straight lines.
42 and 43, the elastic member 30 may protrude from the outer edge of the support surface 21S when viewed from the direction facing the support surface 21S.

[薬剤投与器具の構成]
図44〜図47を参照して、薬剤投与器具の構成について説明する。薬剤投与器具は、上述の経皮投与デバイス10と薬剤の投与対象に巻きつけられる投与補助具とを含んで構成される。
図44〜図46を参照して、投与補助具の構成について説明する。
[Configuration of drug administration device]
The configuration of the drug administration device will be described with reference to FIGS. The drug administration device includes the above-described transdermal administration device 10 and an administration aid wrapped around a drug administration target.
The configuration of the administration aid will be described with reference to FIGS.

図44が示すように、投与補助具50は、帯状に延びるバンド部51と、バンド部51の延びる方向における両端部を互いに固定可能に構成された固定部52と、薬剤の投与位置を規定する投与位置規定部53とを備えている。   As shown in FIG. 44, the administration aid 50 defines a band part 51 extending in a band shape, a fixing part 52 configured to fix both end parts in the extending direction of the band part 51 to each other, and a drug administration position. And an administration position defining portion 53.

バンド部51は、薬剤の投与対象の肢体に巻きつけることの可能な可撓性を有する。バンド部51を構成する材料は、こうした可撓性を実現可能な材料であれば特に限定されず、材料としては、例えば、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、ポリブタジエン、エチレン−酢酸ビニル共重合体(EVA)等のポリオレフィン、ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート(PBT)等のポリエステル、ポリ塩化ビニリデン、シリコン、ポリウレタン、ポリアミドエラストマー、ポリウレタンエラストマー、ポリエステルエラストマー等の各種熱可塑性エラストマー等が挙げられる。なお、バンド部51は、バンド部51の巻き付いている部分の皮膚を視認可能な程度の透明性を有することが好ましい。これにより、投与補助具50の外側から皮膚の各部位を視認することができるため、投与補助具50を肢体に固定する際における薬剤の投与予定位置の確認や、薬剤が投与された位置の確認等が容易である。バンド部51の長さは、薬剤の投与部位が位置する肢体の部分に応じた長さであればよい。   The band part 51 has the flexibility which can be wound around the limb of the medicine administration target. The material which comprises the band part 51 will not be specifically limited if it is a material which can implement | achieve such flexibility, As a material, for example, polyvinyl chloride, polyethylene, a polypropylene, polybutadiene, an ethylene-vinyl acetate copolymer ( Examples thereof include polyolefins such as EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicon, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer. In addition, it is preferable that the band part 51 has the transparency which can visually recognize the skin of the part around which the band part 51 is wound. Thereby, since each site | part of skin can be visually recognized from the outer side of the administration assistance tool 50, confirmation of the administration position of a chemical | medical agent at the time of fixing the administration assistance tool 50 to a limb, and confirmation of the position where the chemical | medical agent was administered Etc. are easy. The length of the band part 51 should just be the length according to the part of the limb where the administration site | part of a chemical | medical agent is located.

固定部52は、バンド部51の延びる方向における2つの端部を互いに固定するための構造を有する。例えば、固定部52は、2つの固定部52a,52bから構成された面ファスナーであって、面ファスナーの雄側である固定部52aは、バンド部51の表面における上記2つの端部の一方に位置し、面ファスナーの雌側である固定部52bは、バンド部51の裏面における上記2つの端部の他方に位置する。なお、面ファスナーに限らず、固定部52は、例えば、スナップボタン、ボタンとボタン孔、クリップ、バンド部51の2つの端部を通して留める枠状の部材であってもよい。   The fixing portion 52 has a structure for fixing two end portions in the extending direction of the band portion 51 to each other. For example, the fixing portion 52 is a hook-and-loop fastener composed of two fixing portions 52 a and 52 b, and the fixing portion 52 a on the male side of the hook-and-loop fastener is attached to one of the two end portions on the surface of the band portion 51. The fixing portion 52 b that is located and is the female side of the hook-and-loop fastener is located on the other of the two end portions on the back surface of the band portion 51. Note that the fixing portion 52 is not limited to a hook-and-loop fastener, and may be a frame-like member that is fastened through two end portions of a snap button, a button and a button hole, a clip, and a band portion 51, for example.

投与位置規定部53は、バンド部51の延びる方向における中央部に設けられた開口部54と開口部54を塞ぐように開閉可能に設けられた蓋部55とから構成される。開口部54は、経皮投与デバイス10の支持面21Sを挿入可能な大きさを有しており、例えば、支持面21Sとほぼ等しい大きさを有する。   The administration position defining portion 53 includes an opening 54 provided at the center in the extending direction of the band portion 51 and a lid 55 provided so as to be able to be opened and closed so as to close the opening 54. The opening 54 has such a size that the support surface 21S of the transdermal administration device 10 can be inserted. For example, the opening 54 has a size substantially equal to the support surface 21S.

開口部54の周囲には、蓋部55を閉じた状態でバンド部51に固定するための構造が設けられている。また、蓋部55は、蓋部55が閉じられたときに開口部54内で皮膚と対向する位置に、薬剤の投与部位を保護するとともに投与された薬剤が皮膚の表面に漏れ出ることを抑える保護部56を備えている。   Around the opening 54, a structure for fixing the band portion 51 in a state where the lid portion 55 is closed is provided. The lid 55 protects the administration site of the drug at a position facing the skin within the opening 54 when the lid 55 is closed, and suppresses the administered drug from leaking to the surface of the skin. A protection unit 56 is provided.

保護部56は、例えば、ガーゼやスポンジのように通気性と吸湿性を有するパッド部材とパッド部材を皮膚に押し付けるための板状の補助部材とから構成される。パッド部材としてスポンジが用いられる場合、スポンジの吸水膨潤率は100%以上であることが好ましく、300%以上であることがさらに好ましい。また、乾燥時におけるスポンジの厚さは0.5mm以上であることが好ましく、0.8mm以上であることがさらに好ましい。スポンジは、生体親和性がある材質を有することが好ましく、こうしたスポンジとしては、セルローススポンジが容易に入手できるため好ましい。なお、パッド部材が投与された薬剤を過剰に吸い取ることを抑えるために、撥水性を有するシート等が保護部56に含まれていてもよい。   The protection part 56 is comprised from the plate-shaped auxiliary member for pressing the pad member which has air permeability and moisture absorption like gauze and sponge, and a pad member to skin, for example. When a sponge is used as the pad member, the water absorption swelling rate of the sponge is preferably 100% or more, and more preferably 300% or more. Further, the thickness of the sponge at the time of drying is preferably 0.5 mm or more, and more preferably 0.8 mm or more. The sponge preferably has a biocompatible material, and such a sponge is preferable because a cellulose sponge is easily available. It should be noted that a sheet having water repellency or the like may be included in the protection unit 56 in order to prevent excessive absorption of the medicine to which the pad member has been administered.

図45や図46が示すように、肢体Liである手首や腕の外側を1周するように、バンド部51が肢体Liに巻きつけられ、固定部52aが固定部52bに重ねられてこれらの固定部52a,52bが互いに固定されることによって、投与補助具50が肢体Liに固定される。このとき、投与位置規定部53の開口部54が薬剤を投与する予定の位置に配置されるように、肢体Liに対するバンド部51の位置が決定される。
図47が示すように、薬剤投与器具40は、経皮投与デバイス10と投与補助具50とから構成される。
As shown in FIG. 45 and FIG. 46, the band portion 51 is wound around the limb Li so as to go around the wrist and arm that are the limb Li, and the fixing portion 52a is overlapped with the fixing portion 52b so that these By fixing the fixing portions 52a and 52b to each other, the administration aid 50 is fixed to the limb Li. At this time, the position of the band part 51 with respect to the limb Li is determined so that the opening 54 of the administration position defining part 53 is disposed at a position where the medicine is to be administered.
As shown in FIG. 47, the drug administration device 40 includes a transdermal administration device 10 and an administration aid 50.

薬剤投与器具40が薬剤の投与に用いられるとき、経皮投与デバイス10の基体部21における支持面21Sと反対側の筒端には、シリンジ60の外筒61の先端部が接続される。基体部21の筒端には、外筒61の先端部を接続するための構造が設けられていればよい。   When the drug administration device 40 is used for drug administration, the distal end portion of the outer cylinder 61 of the syringe 60 is connected to the cylinder end of the base 21 of the transdermal administration device 10 opposite to the support surface 21S. It suffices if a structure for connecting the distal end portion of the outer cylinder 61 is provided at the cylinder end of the base portion 21.

経皮投与デバイス10は、支持面21Sを開口部54に向けて開口部54に挿入され、突起部22が皮膚に刺される。シリンジ60のピストン62が押下されることによって、外筒61内に収容されている薬剤が基体部21の内部に供給され、さらに、薬剤は貫通孔23を通って突起部22の先端から出る。シリンジ60の外筒61は透明もしくは半透明であって、外筒61には薬剤の充填量を示す目盛りが付されているため、外筒61内に充填されている薬剤の量を外部から確認することが可能であり、所望の量の薬剤を正確に投与しやすい。   The transdermal administration device 10 is inserted into the opening 54 with the support surface 21S facing the opening 54, and the protrusion 22 is stabbed into the skin. When the piston 62 of the syringe 60 is pressed, the medicine accommodated in the outer cylinder 61 is supplied to the inside of the base portion 21, and further, the medicine passes through the through hole 23 and comes out from the tip of the projection portion 22. The outer cylinder 61 of the syringe 60 is transparent or translucent, and the outer cylinder 61 is provided with a scale indicating the filling amount of the medicine, so that the amount of medicine filled in the outer cylinder 61 is confirmed from the outside. It is easy to accurately administer the desired amount of drug.

なお、基体部21に薬剤を供給するための器具は、シリンジ60に限られず、加圧によって薬剤を基体部21の内部および貫通孔23に流して突起部22の先端から放出させることのできる器具であればよい。   Note that the instrument for supplying the drug to the base portion 21 is not limited to the syringe 60, and a tool that allows the drug to flow through the inside of the base portion 21 and the through hole 23 by pressure and be released from the tip of the protrusion 22. If it is.

なお、図48が示すように、薬剤の投与に用いられる前、すなわち、シリンジ60に組み付けられて投与補助具50の開口部54に挿入される前の経皮投与デバイス10は、カバー部材70によって保護されていることが好ましい。カバー部材70は、弾性部材30の有する面のうち支持面21Sに接する面とは反対側の面と、突起部22のなかで弾性部材30から飛び出ている部分とを覆う形状を有し、弾性部材30に剥離可能に貼り付けられている。   As shown in FIG. 48, the transdermal administration device 10 before being used for drug administration, that is, before being inserted into the opening 54 of the administration aid 50 after being assembled into the syringe 60, is covered by the cover member 70. It is preferably protected. The cover member 70 has a shape that covers the surface of the elastic member 30 opposite to the surface in contact with the support surface 21S and the portion of the protrusion 22 that protrudes from the elastic member 30 and is elastic. Affixed to the member 30 so as to be peelable.

例えば、カバー部材70は、突起部22のなかで弾性部材30から飛び出ている部分を囲む凹部と、凹部の端部から張り出して弾性部材30の支持面21Sに接する面とは反対側の面に貼り付けられる部分とから構成される。また、カバー部材70は、カバー部材70を弾性部材30から剥離する際に使用者が指で摘むことのできる部分を有していると、カバー部材70の剥離が容易であるため好ましい。   For example, the cover member 70 has a recess surrounding the protruding portion 22 protruding from the elastic member 30 and a surface on the opposite side of the surface protruding from the end of the recess and contacting the support surface 21S of the elastic member 30. It consists of a part to be pasted. In addition, it is preferable that the cover member 70 has a portion that can be picked with a finger when the cover member 70 is peeled off from the elastic member 30 because the cover member 70 can be easily peeled off.

カバー部材70を構成する材料は特に限定されないが、材料としては、射出成形加工もしくはプレス加工による成形を容易に行うことのできる樹脂が好ましい。また、カバー部材70が、透明もしくは半透明であれば、カバー部材の70の内部を外から視認できるため好ましい。また、カバー部材70は、空気や水蒸気の透過性が小さく、長期にわたって経皮投与デバイス10を安定に保護できることが好ましい。こうしたカバー部材70を実現可能な材料としては、ポリエチレンテレフタレート(PET)、ポリプロピレン(PP)、ポリエチレン(PE)が用いられることが好ましく、特に、PETは、γ線や電子線照射滅菌による劣化や発臭が少ないため好ましい。   Although the material which comprises the cover member 70 is not specifically limited, As a material, resin which can perform the shaping | molding by injection molding process or press work easily is preferable. Moreover, it is preferable that the cover member 70 is transparent or translucent because the inside of the cover member 70 can be visually recognized from the outside. Moreover, it is preferable that the cover member 70 has small permeability of air and water vapor and can stably protect the transdermal administration device 10 over a long period of time. Polyethylene terephthalate (PET), polypropylene (PP), and polyethylene (PE) are preferably used as a material that can realize such a cover member 70. In particular, PET is deteriorated or emitted by γ-ray or electron beam irradiation sterilization. Since there is little odor, it is preferable.

カバー部材70に覆われた状態で経皮投与デバイス10が保管されることによって、弾性部材30のなかで皮膚に貼り付けられる面の粘着性の低下が抑えられるとともに、突起部22が外部の物品等と接触して変形することが抑えられる。   By storing the transdermal administration device 10 in a state of being covered with the cover member 70, it is possible to suppress a decrease in the adhesiveness of the surface of the elastic member 30 to be affixed to the skin, and the protrusion 22 is an external article. It is possible to suppress deformation due to contact with the like.

[薬剤投与器具を用いた薬剤の投与]
図49〜図52を参照して、薬剤投与器具40を用いた薬剤の投与の手順について説明する。
薬剤投与器具40の使用者は、開口部54が薬剤を投与する予定の位置に配置されるように、投与補助具50を投与対象の肢体に固定する。このとき、図49が示すように、蓋部55は開けられ、開口部54内には皮膚Skが露出している。経皮投与デバイス10には、薬剤Mが充填されたシリンジ60が接続され、使用者は、突起部22の先端を開口部54内に露出した皮膚Skに向けて、経皮投与デバイス10を開口部54に挿入して皮膚Skに押し付ける。
[Drug administration using drug administration device]
With reference to FIG. 49 to FIG. 52, a procedure of drug administration using the drug administration device 40 will be described.
The user of the drug administration device 40 fixes the administration aid 50 to the limb of the administration target so that the opening 54 is disposed at a position where the drug is to be administered. At this time, as shown in FIG. 49, the lid 55 is opened, and the skin Sk is exposed in the opening 54. A syringe 60 filled with the medicine M is connected to the transdermal administration device 10, and the user opens the transdermal administration device 10 with the tip of the protrusion 22 facing the skin Sk exposed in the opening 54. Insert into part 54 and press against skin Sk.

図50が示すように、突起部22と弾性部材30と支持面21Sおよび支持面21Sの付近の基体部21とは、開口部54内に挿入され、突起部22は角質層を貫通して皮膚Skに刺さる。このとき、弾性部材30は押圧力を受けて突起部22の延びる方向に圧縮された状態で、皮膚Skの表面に接触する。使用者は、経皮投与デバイス10を皮膚Skに強く押し付けた後、その押圧力を弱める。   As shown in FIG. 50, the protruding portion 22, the elastic member 30, the supporting surface 21S, and the base portion 21 near the supporting surface 21S are inserted into the opening 54, and the protruding portion 22 penetrates the stratum corneum and the skin. Sting the Sk. At this time, the elastic member 30 contacts the surface of the skin Sk in a state where the elastic member 30 is compressed in the extending direction of the protruding portion 22 under a pressing force. The user presses the transdermal administration device 10 strongly against the skin Sk and then weakens the pressing force.

図51が示すように、使用者が、経皮投与デバイス10に加えている押圧力を弱めると、弾性部材30が復元し、弾性部材30の厚みの増加に伴って、基体部21と突起部22とは皮膚Skの表面から離れる方向に動く。このとき、弾性部材30が皮膚Skの表面に貼り付いているため、突起部22が皮膚Skから抜け出たり突起部22が皮膚Skの中で傾いたりすることが抑えられる。   As shown in FIG. 51, when the user weakens the pressing force applied to the transdermal administration device 10, the elastic member 30 is restored, and the base portion 21 and the protruding portion are increased as the thickness of the elastic member 30 increases. 22 moves away from the surface of the skin Sk. At this time, since the elastic member 30 is adhered to the surface of the skin Sk, the protrusion 22 is prevented from slipping out of the skin Sk or the protrusion 22 is tilted in the skin Sk.

これにより、皮膚Skに対する押圧が弱められ、この状態で、使用者はシリンジ60のピストン62を押圧する。その結果、シリンジ60から基体部21の内部空間に供給された薬剤Mは、基体部21の内部と貫通孔23とを通って突起部22の先端から出て、皮内に拡散される。皮膚Skに対する押圧が弱められていることにより、皮内に薬剤が拡散しやすくなっているため、薬剤を円滑に投与することができる。また、投与補助具50によって開口部54の位置に薬剤の投与予定位置が規定され、開口部54の位置に応じて突起部22を皮膚Skに刺すことによって薬剤の投与位置が決定できるため、薬剤を投与する位置の位置決めが容易である。また、薬剤の投与中にも突起部22および支持面21Sは開口部54内に位置するため、皮膚Skに対する経皮投与デバイス10の位置の安定性が高められる。   Thereby, the press with respect to skin Sk is weakened, and a user presses piston 62 of syringe 60 in this state. As a result, the medicine M supplied from the syringe 60 to the internal space of the base body portion 21 passes through the inside of the base body portion 21 and the through hole 23, exits from the tip of the protrusion 22, and is diffused into the skin. Since the pressure on the skin Sk is weakened, the drug can easily diffuse into the skin, so that the drug can be smoothly administered. In addition, since the administration assisting device 50 defines the scheduled administration position of the drug at the position of the opening 54, and the drug 22 can be determined by piercing the skin Sk according to the position of the opening 54, the drug administration position can be determined. It is easy to position the position to administer. Further, since the protrusion 22 and the support surface 21S are located in the opening 54 even during the administration of the drug, the stability of the position of the transdermal administration device 10 with respect to the skin Sk is improved.

図52が示すように、薬剤の投与が完了すると、使用者は、経皮投与デバイス10を開口部54から引き上げ、蓋部55を閉じる。これにより、保護部56が皮膚Skにおける薬剤の投与部位に接し、薬剤の投与部位が保護されるとともに、投与された薬剤が皮膚Skの表面に漏れ出ることが抑えられる。したがって、投与された薬剤の体内への浸透が補助される。   As shown in FIG. 52, when the administration of the medicine is completed, the user pulls up the transdermal administration device 10 from the opening 54 and closes the lid 55. Thereby, the protection part 56 contacts the administration site of the drug in the skin Sk, the administration site of the drug is protected, and the administered drug is prevented from leaking to the surface of the skin Sk. Therefore, penetration of the administered drug into the body is assisted.

なお、投与補助具50を利用せずに、経皮投与デバイス10を用いて薬剤の投与を行ってもよいが、上述のように、投与補助具50を利用することによって、容易に薬剤の投与を行うことができる。   Note that the drug may be administered using the transdermal administration device 10 without using the administration aid 50. However, as described above, the administration of the drug can be easily performed by using the administration aid 50. It can be performed.

以上説明したように、本実施形態の経皮投与デバイスおよび薬剤投与器具によれば、以下の効果が得られる。
(1)支持面21Sに弾性部材30が配置されているため、投与対象の皮膚に突起部22が刺さる程度に、経皮投与デバイス10が皮膚に押し付けられたとき、支持面21Sと皮膚の表面との間で弾性部材30が圧縮された状態で弾性部材30が皮膚の表面に貼り付く。そして、経皮投与デバイス10に加えられている押圧力が弱められると、弾性部材30の形状が復元することに伴って、基体部21と突起部22とは皮膚の表面から離れる方向に動き、経皮投与デバイス10による皮膚に対する押圧が弱められる。このとき、弾性部材30が皮膚の表面に貼り付いているため、支持面21Sが皮膚の表面から過剰に離れること、ひいては、突起部22が皮膚から抜け出てしまうことが抑えられる。したがって、角質層を貫通するように力を加えて突起部22を皮膚に刺しつつも、刺さった突起部22が皮膚から抜け出ることを抑えながら皮膚への押圧を弱めて、皮内へ薬剤が浸透しやすくすることが可能であり、この状態で貫通孔23を通じて薬剤を投与することによって、薬剤の円滑な投与が可能である。
As described above, according to the transdermal administration device and drug administration device of the present embodiment, the following effects can be obtained.
(1) Since the elastic member 30 is disposed on the support surface 21S, when the transdermal administration device 10 is pressed against the skin to such an extent that the protrusion 22 is stuck in the skin to be administered, the support surface 21S and the surface of the skin The elastic member 30 sticks to the surface of the skin in a state where the elastic member 30 is compressed therebetween. When the pressing force applied to the transdermal administration device 10 is weakened, the base portion 21 and the protruding portion 22 move away from the skin surface as the shape of the elastic member 30 is restored. The pressure on the skin by the transdermal administration device 10 is weakened. At this time, since the elastic member 30 is adhered to the surface of the skin, it is possible to prevent the support surface 21S from being excessively separated from the surface of the skin and, in turn, the protruding portion 22 from slipping out of the skin. Therefore, while applying a force to penetrate the stratum corneum and piercing the protrusion 22 into the skin, the drug penetrates into the skin by reducing the pressure on the skin while suppressing the pierced protrusion 22 from coming out of the skin. In this state, by administering the drug through the through hole 23, the drug can be smoothly administered.

(2)支持面21Sと対向する方向から見て、弾性部材30が突起部22の周囲を取り囲んでいる構成では、突起部22の周囲を取り囲む位置で、経皮投与デバイス10が皮膚に貼り付くため、皮膚に対する突起部22の位置の安定性が高められる。   (2) In the configuration in which the elastic member 30 surrounds the protrusion 22 when viewed from the direction facing the support surface 21S, the transdermal administration device 10 sticks to the skin at a position surrounding the protrusion 22. Therefore, the stability of the position of the protrusion 22 with respect to the skin is improved.

(3)支持面21Sと対向する方向から見て、弾性部材30が複数の突起部22からなる集合を取り囲んでいる構成では、弾性部材30が突起部22を1つずつ取り囲む構成と比較して、弾性部材30の形状が複雑になることや弾性部材30における形状の精度が得られがたくなることが抑えられるため、弾性部材30の形成が容易である。   (3) When viewed from the direction facing the support surface 21S, the structure in which the elastic member 30 surrounds the set of the plurality of protrusions 22 is compared to the structure in which the elastic member 30 surrounds the protrusions 22 one by one. Further, since the shape of the elastic member 30 is complicated and it is difficult to obtain the shape accuracy of the elastic member 30, it is easy to form the elastic member 30.

(4)支持面21Sと対向する方向から見て、弾性部材30が突起部22を1つずつ取り囲んでいる構成では、複数の突起部22からなる集合を1つの弾性部材30が取り囲む形態と比較して、支持面21Sにおいて弾性部材30が占有する面積を大きく確保しやすい。したがって、皮膚の表面に貼り付く弾性部材30の面積を大きく確保しやすいため、皮膚に対する突起部22の位置の安定性が高められる。   (4) When viewed from the direction facing the support surface 21S, the configuration in which the elastic member 30 surrounds the protrusions 22 one by one is compared with the configuration in which one elastic member 30 surrounds a set of the plurality of protrusions 22. Thus, it is easy to secure a large area occupied by the elastic member 30 on the support surface 21S. Therefore, since it is easy to ensure a large area of the elastic member 30 attached to the surface of the skin, the stability of the position of the protrusion 22 with respect to the skin is enhanced.

(5)経皮投与デバイス10が複数の弾性部材30を備える構成では、弾性部材30の配置や弾性部材30の発揮する機能についての調整の自由度が高められる。   (5) In the configuration in which the transdermal administration device 10 includes a plurality of elastic members 30, the degree of freedom in adjustment of the arrangement of the elastic members 30 and the functions exhibited by the elastic members 30 is increased.

(6)複数の弾性部材30に、弾性部材30の弾性率や、弾性部材30の有する粘着性や、突起部22の延びる方向における弾性部材30の長さが異なる弾性部材が含まれる。こうした構成によれば、支持面21S内での位置による押圧力のばらつきや薬剤の投与部位内での皮膚の伸びやすさのばらつき等に応じて、突起部22における皮膚に刺さる長さを調整することや、支持面21S内での位置に応じて経皮投与デバイス10が皮膚に貼り付く強さを調整することができる。   (6) The plurality of elastic members 30 include elastic members having different elastic moduli, elastic properties of the elastic members 30, and different lengths of the elastic members 30 in the direction in which the protrusions 22 extend. According to such a configuration, the length of the protrusion 22 to be pierced by the skin is adjusted in accordance with variations in pressing force depending on the position in the support surface 21S, variations in the easiness of the skin in the drug administration site, and the like. In addition, the strength with which the transdermal administration device 10 sticks to the skin can be adjusted according to the position within the support surface 21S.

(7)弾性部材30が、突起部22の延びる方向における弾性部材30の長さが各々で異なる複数の部位を有する構成では、支持面21S内での位置に応じて皮膚に刺さる突起部22の長さや皮膚の伸びを調整したり、経皮投与デバイス10の皮膚への貼り付き方を調整したりすることができる。   (7) In the configuration in which the elastic member 30 has a plurality of portions in which the length of the elastic member 30 in the extending direction of the protrusion 22 is different, the protrusion 22 that pierces the skin according to the position in the support surface 21S. The length and the elongation of the skin can be adjusted, and how the transdermal administration device 10 is attached to the skin can be adjusted.

(8)経皮投与デバイス10を投与補助具50とともに用い、投与補助具50を薬剤の投与対象に巻き付けた後、開口部54に経皮投与デバイス10を挿入して突起部22を開口部54内の皮膚に刺し、薬剤を投与することによって、皮膚に対する経皮投与デバイス10の位置決め、すなわち、薬剤を投与する位置の位置決めを容易に行うことができる。また、薬剤の投与中における皮膚に対する経皮投与デバイス10の位置の安定性も高められる。さらに、薬剤の投与後に蓋部55によって開口部54を塞ぐことにより、投与された薬剤の体内への浸透が補助される。したがって、経皮投与デバイス10を用いた円滑な薬剤の投与を容易に進めることができる。   (8) The transdermal administration device 10 is used together with the administration aid 50, and the administration aid 50 is wound around the administration target of the medicine, and then the transdermal administration device 10 is inserted into the opening 54 to insert the protrusion 22 into the opening 54. By piercing the inner skin and administering the drug, it is possible to easily position the transdermal administration device 10 with respect to the skin, that is, the position where the drug is administered. In addition, the stability of the position of the transdermal administration device 10 with respect to the skin during the administration of the drug is improved. Furthermore, by closing the opening 54 with the lid portion 55 after the administration of the drug, penetration of the administered drug into the body is assisted. Therefore, smooth drug administration using the transdermal administration device 10 can be facilitated.

10…経皮投与デバイス、20…マイクロニードル、21…基体部、21S…支持面、22…突起部、23…貫通孔、30…弾性部材、40…薬剤投与器具、50…投与補助具、51…バンド部、52…固定部、53…投与位置規定部、54…開口部、55…蓋部、60…シリンジ、70…カバー部材。   DESCRIPTION OF SYMBOLS 10 ... Transdermal administration device, 20 ... Microneedle, 21 ... Base | substrate part, 21S ... Support surface, 22 ... Protrusion part, 23 ... Through-hole, 30 ... Elastic member, 40 ... Drug administration instrument, 50 ... Administration aid, 51 ... Band part, 52 ... Fixing part, 53 ... Administration position defining part, 54 ... Opening part, 55 ... Lid part, 60 ... Syringe, 70 ... Cover member.

Claims (8)

薬剤を通す筒状の基体部であって、当該基体部における2つの筒端の一方に支持面を有する前記基体部と、
前記支持面から突き出た突起部であって、前記突起部の延びる方向に当該突起部を貫通して前記基体部の内部空間に連通する貫通孔が形成されている前記突起部と、
前記支持面に位置し、粘着性を有した弾性体である弾性部材と、
を備える経皮投与デバイス。
A cylindrical base part for passing a medicine, the base part having a support surface at one of two cylindrical ends of the base part;
A protrusion protruding from the support surface, the protrusion being formed with a through-hole penetrating the protrusion in the extending direction of the protrusion and communicating with the internal space of the base body;
An elastic member which is an elastic body located on the support surface and having adhesiveness;
A transdermal administration device comprising:
前記支持面と対向する方向から見て、前記弾性部材は、前記突起部の周囲を取り囲んでいる
請求項1に記載の経皮投与デバイス。
The transdermal administration device according to claim 1, wherein the elastic member surrounds the periphery of the protrusion when viewed from a direction facing the support surface.
前記経皮投与デバイスは、複数の前記突起部を備え、
前記支持面と対向する方向から見て、前記弾性部材は、前記複数の突起部からなる集合を取り囲んでいる
請求項2に記載の経皮投与デバイス。
The transdermal administration device comprises a plurality of the protrusions,
The transdermal administration device according to claim 2, wherein the elastic member surrounds a set of the plurality of protrusions when viewed from a direction facing the support surface.
前記経皮投与デバイスは、複数の前記突起部を備え、
前記支持面と対向する方向から見て、前記弾性部材は、前記突起部を1つずつ取り囲んでいる
請求項2に記載の経皮投与デバイス。
The transdermal administration device comprises a plurality of the protrusions,
The transdermal administration device according to claim 2, wherein the elastic member surrounds the protrusions one by one when viewed from a direction facing the support surface.
前記経皮投与デバイスは、複数の前記弾性部材を備える
請求項1に記載の経皮投与デバイス。
The transdermal administration device according to claim 1, wherein the transdermal administration device includes a plurality of the elastic members.
前記複数の弾性部材には、特性の異なる複数の前記弾性部材が含まれ、前記特性は、前記弾性部材の弾性率、前記弾性部材の有する粘着性、および、前記突起部の延びる方向における前記弾性部材の最大の長さの少なくとも1つである
請求項5に記載の経皮投与デバイス。
The plurality of elastic members include a plurality of elastic members having different characteristics, and the characteristics include the elastic modulus of the elastic member, the adhesiveness of the elastic member, and the elasticity in the extending direction of the protrusion. The transdermal administration device according to claim 5, wherein the transdermal administration device is at least one of the maximum lengths of the members.
前記突起部の延びる方向における前記弾性部材の長さが各々で異なる複数の部位を前記弾性部材が有する
請求項1に記載の経皮投与デバイス。
The transdermal administration device according to claim 1, wherein the elastic member has a plurality of portions each having a different length of the elastic member in the extending direction of the protrusion.
請求項1〜7のいずれか一項に記載の経皮投与デバイスと、
薬剤の投与対象に巻きつけられる投与補助具と、を備える薬剤投与器具であって、
前記投与補助具は、
帯状に延びるバンド部と、
前記バンド部に形成された開口部であって、前記経皮投与デバイスの前記支持面を挿入可能な大きさを有する前記開口部、および、前記開口部を塞ぐように開閉可能な蓋部を含む投与位置規定部と、
前記バンド部の延びる方向における当該バンド部の両端部を互いに固定可能に構成された固定部と、を備える
薬剤投与器具。
A transdermal administration device according to any one of claims 1 to 7,
A drug administration device comprising: an administration aid wrapped around a drug administration target,
The administration aid is
A band portion extending in a band shape;
An opening formed in the band, the opening having a size capable of inserting the support surface of the transdermal administration device, and a lid that can be opened and closed so as to close the opening An administration position defining part;
A drug administration device comprising: a fixing part configured to fix both end parts of the band part in a direction in which the band part extends.
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JP2005087521A (en) * 2003-09-18 2005-04-07 Terumo Corp Liquid medicine injector
JP2007014594A (en) * 2005-07-08 2007-01-25 Ltt Bio-Pharma Co Ltd Chemicals feeder
JP2012515604A (en) * 2009-01-23 2012-07-12 ドン ハン カン Skin treatment device
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